Study Assignments
Neurology – Epilepsy
A Phase 1, Single- and Multiple-Dose, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered XXXX in Healthy Male and Female Subjects
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Other – Tobacco
A Single-blind, Two-way Crossover Study to Assess Nicotine Uptake and Product Use Behavior in Moist Snuff Consumers Using Two Moist Snuff Products
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Autoimmune Diseases – Psoriasis, Ulcerative Colitis, RA
An Open Label, Randomized, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of XXXX Given as 2x1mL or 1x2mL Subcutaneous Administration in Healthy Subjects
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Mental Disorders – Schizophrenia
A Phase 1, Open-Label, Parallel-Design, Single Dose Study to Assess the Relative Bioavailability of XXXX Extended-Release Suspension for Subcutaneous Administration (XXXX), in Prefilled Syringes compared to Vials, in Patients with Schizophrenia or Schizoaffective Disorder
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Endocrine/Metabolic – Recurring Multiple Sclerosis, Ulcerative Colitis and Crohn’s Disease
A Phase 1, Multi-center, Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of XXXX and Active Metabolites in Healthy Adult Subjects
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Endocrine/Metabolic – Recurring Multiple Sclerosis, Ulcerative Colitis and Crohn’s Disease
A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled Study to Evaluate the Effect of XXXX on Pressor Response to Oral Tyramine in Healthy Adult Subjects
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Endocrine/Metabolic – Type 1 Diabetes
A 2-Stage Study Using Blood Collected from Adults with Type-1 Diabetes to Assess Autoantigen Peptides
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Cardiovascular – Critical Limb Ischemia
A Phase 1, Double-blind, Placebo-controlled, Randomized, Two-Part, Ascending Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XXX in Healthy Participants
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Endocrine/Metabolic – Recurring Multiple Sclerosis, Ulcerative Colitis and Crohn’s Disease
A Phase 1, Randomized, Parallel-group, Open-label Study to Evaluate the Effect of the Modulators of the Cytochrome P450 (CYP) 2C8 and/or 3A on the Single-dose Pharmacokinetics of XXXX and XXXX in Healthy Adult Subjects
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Nephrology – Autosomal Dominant Polycystic Kidney Disease
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of XXXX Administered via Subcutaneous Injection
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Oncology – Immunomodulation-based therapy
A Randomized, Open-Label, Four-Cohort, Parallel Design Study to Evaluate the Effect of XXXX or XXXX on the Single-dose Pharmacokinetics of XXXX in Normal Healthy Participants
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Study Closeout, Trial Master File reconciliation
Nephrology – Autosomal Dominant Polycystic Kidney Disease
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Injected XXXX in Healthy Adult Subjects
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Study Closeout, Trial Master File reconciliation
Cardiovascular – Thrombosis
Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of XXXX in Healthy Japanese Participants
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Study Closeout, Trial Master File reconciliation
Musculoskeletal – Muscular Dystrophy
An Open-label, Randomized, Parallel-group, Single Dose Study to Compare the Bioavailability of Subcutaneous Injections in the Arm, Thigh, and Abdomen and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of XXXX in Healthy Participants
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Medical Device – Cigarette Filter
A Crossover Study to Evaluate the Exposure to “Tar” and Nicotine from Two 100s Menthol Cigarette Products
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Medical Device – Cigarette Filter
A Crossover Study to Evaluate the Exposure to “Tar” and Nicotine from Two King Size Menthol Cigarette Products
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Women’s Health – Preterm Birth
A Multi-Center, Randomized, Open-Label Study Comparing Bioavailability when Preservative-free XXXX is Administered as a 1 mL Intramuscular (IM) Manual Injection or as a 1.1 mL Subcutaneous (SQ) Injection using an Auto-injector in Healthy Post-menopausal Women
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Infectious Diseases – Smallpox
A Phase 1, Open-Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral XXXX in Subjects with Varying Degrees of Renal Impairment and Healthy Matched Control Subjects with Normal Renal Function
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Infectious Diseases – Smallpox
A Phase 1, Open-Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral XXXX in Subjects with Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects with Normal Hepatic Function.
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Women’s Health – Hot Flashes
Evaluation of the Pharmacokinetics and Safety of XXXX in Post-Menopausal Women with Vasomotor Symptoms
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Neurology – Multiple Sclerosis
A Phase 1, Open-label Study to Characterize the Pharmacokinetics and Safety of a Single Oral Dose of XXXX in Subjects with Hepatic Impairment
Counties handled: USA (3 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Oncology – Neutropenia
A Randomized, Double-Blind, 2-Period Parallel-Arm Study to Assess the Immunogenicity of 2 subcutaneous doses of XXXX and 2 subcutaneous doses XXXX in Healthy Subjects
Responsibilities:
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Oncology – Neutropenia
A Randomized, Double-Blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Biosimilarity of XXXX with XXXX in Healthy Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Co-Monitoring
Infectious Diseases - Ebola
A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study With an Additional Multiple-Dose Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of XXXX in Healthy Human Volunteers
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Monitoring and Study Closeout, Trial Master File reconciliation
Acute Pain
A Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various XXXX Formulations in Healthy Male Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Oncology – Neutropenia
A Randomized, Double-Blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Biosimilarity of XXXX with XXXX in Healthy Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Device
Feasibility Trial to Evaluate the XXXX Continuous Glucose Monitoring System
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study Closeout, Trial Master File reconciliation
Acute Pain
A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacodynamics And Pharmacokinetics of TRV734 in Healthy Adult Male and Female Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Infectious Diseases - HIV
A Study to Evaluate the Effect of Food on the Pharmacokinetics of XXXX from an Extended-Release Formulation of XXXX in Healthy Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Oncology - Metastatic breast cancer, early breast cancer, and metastatic gastric cancer
A Randomized, Single-Blind, Single-Dose, 3-Arm, Parallel Group Study to Determine the Pharmacokinetic Equivalence of XXXX and XXXX in Healthy Male Subjects
Responsibilities:
- Counties handled: Australia (1 site)
- Study stage handled: CRA training, dose observation
Infectious Disease – Hepatitis C
An Open-label, Randomized, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Daclatasvir, Asunaprevir, and XXXX Following Administration of a Single Fixed Dose Combination of XXXX FDC in Healthy Subjects
Responsibilities:
- Counties handled: USA (1 site)
Infectious Disease – Hepatitis C
An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a
Fixed Dose Combination Formulation of DCV, ASV, and XXXX in Subjects with Normal Renal Function
and Subjects with Mild, Moderate, Severe, and End-stage Renal Dysfunction
Responsibilities:
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Infectious Disease – Hepatitis C
A Phase 1, Open-Label, Drug-Drug Interaction Study between Methadone and XXXX + 75 mg XXXX, and between Buprenorphine/Naloxone and Daclatasvir/Asunaprevir/XXXX + 75 XXXX
Responsibilities:
- Counties handled: USA (3 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Acute Pain
A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral XXX in Healthy Adult Male Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout,
- Trial Master File reconciliation
Diabetes
A phase I, randomized, placebo-controlled, single dose escalation study to investigate safety, pharmacokinetics and pharmacodynamics of XXXX in healthy volunteers
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Acute Pain
An Open-Label Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XXXX in Healthy Adults
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Oncology
A Randomized, Partially Double-blind, Placebo- and Positive-Controlled, 3-Arm, Crossover Study to Assess the Effect of XXXX on Electrocardiogram Parameters in Healthy Volunteers, a Thorough ECG/QT Study
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Inflammation
Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetics Study of XXXX and XXXX Sourced from US and EU Administered to Healthy Volunteer
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Pain
An Open-Label Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XXXX in Healthy Adults
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Pain
A Multi-Part, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous XXXX in Healthy Adult Males
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Diabetes
A randomized, double-blind, placebo-controlled, parallel group study to investigate the effects of XXXX 150 μg in type 2 diabetic patients treated with XXXX 20 mg on renal function, the renin-angiotensin system and the pharmacokinetics of XXXX
Responsibilities:
- Counties handled: USA (4 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Non-Small Cell Lung Cancer, Squamous Cell Cancer
A Phase 1 Study to Evaluate the Single Dose
Pharmacokinetics of XXXX in Subjects with Impaired Hepatic Function
Responsibilities:
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Diabetes
Bioequivalence Study of a Fixed-Dose Combination Tablet of 10-mg XXXX/1000-mg XXXX Relative to a Single 10-mg XXXX Tablet and Two 500-mg XXXX Tablets Coadministered to Healthy Subjects in the Fed
and Fasted States and Steady-State Pharmacokinetic Assessment of the Fixed-Dose Combination of 10-mg XXXX/1000-mg XXXX.
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study Closeout, Trial Master File reconciliation
Autoimunne Diseases
A Randomized, Single-Blind, Single-Dose, 3-Arm, Parallel-Group Study to Determine the Pharmacokinetic Equivalence of XXXX and XXXX in Healthy Adult Subjects
Responsibilities:
- Counties handled: USA (1 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout, Trial Master File reconciliation
Small Cell Lung Cancer, Device
A Multi-center, Open-Label, Randomized, Parallel Group Study in Healthy Subjects to Assess the Comparability of a Single Subcutaneous (SC) Dose of XXXX Delivered Manually from a Pre-filled Syringe Versus Delivered by a Delivery Device
Responsibilities:
- Counties handled: USA (1 sites)
- Study stage handled: Study start-up, Monitoring, Trial Master File reconciliation
Solid Tumors
A Randomized, Partially Double-blind, Placebo- and Positive-Controlled, 3-Arm, Crossover Study to Assess the Effect of XXXX on Electrocardiogram Parameters in Healthy Volunteers, a Thorough ECG/QT Study
Responsibilities:
- Counties handled: USA (1 sites)
- Study stage handled: Study start-up, Monitoring,
- Trial Master File reconciliation
Device
A Phase 0, Open-Label, Randomized, Crossover Study to Estimate Pressure Associated with Delivery of 3.5 mL of Placebo Buffer in Healthy Subjects
Responsibilities:
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up,
- Trial Master File reconciliation
Mutant Positive Tumors
An Open Label Study to Examine the Effects of a High-Fat Meal and Particle Size on the Pharmacokinetics of Orally Administered XXXX in Subjects with BRAF Mutation-Positive Tumor.
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Final SMV, Study Closeout
- Trial Master File reconciliation
Mutant Positive Tumors
A Rollover Study to Provide Continued Treatment with XXXX to Subjects with BRAF Mutation-Positive Tumors
Responsibilities:
- Counties handled: USA (1 sites)
- Study stage handled: Monitoring
- Trial Master File reconciliation
Solid Tumors
A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose XXXX on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of XXXX, and the Repeat Dose Pharmacokinetics of XXXX in Subjects with BRAF Mutant Solid Tumors
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring
- Trial Master File reconciliation
Solid Tumors
An Open-Label, Two-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Single Dose
Pharmacokinetics of the MEK Inhibitor, XXXX, in
Subjects with Solid Tumors
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring
- Trial Master File reconciliation
Solid Tumors
A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose XXXX on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of XXXX, and the Repeat Dose Pharmacokinetics of XXXX in Subjects with BRAF Mutant Solid Tumors
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring
- Trial Master File reconciliation
Huntington Disease
A Phase 1b, Open-label, Parallel-group Study in Subjects with Huntington Disease to Assess the Safety, Tolerability, and Fed/Fasted Pharmacokinetics of Repeated Oral Doses of XXXX
Responsibilities:
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up
- Trial Master File reconciliation
Solid Tumors
A Rollover Study to Provide Continued Treatment with XXXX to Subjects with Solid Tumors or Leukemia.
Responsibilities:
- Counties handled: USA (3 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Non-Small Cell Lung Cancer
A Phase II study of the selective BRAF kinase inhibitor
XXXX in subjects with advanced non-small cell lung cancer and BRAF mutations
Responsibilities:
- Counties handled: USA (6 sites)
- Study stage handled: Study start-up, Monitoring
- Trial Master File reconciliation
Acute Coronary Syndrome
The effect of hepatic impairment on the pharmacokinetics of XXXX: A multi-center, open-label study following a single oral dose of XXXX administered to subjects with mild or moderate hepatic impairment and healthy subjects with normal hepatic function.
Responsibilities:
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up, Monitoring
- Trial Master File reconciliation
Bioavailability Study – Solid Tumors
An open-label, Phase 1, randomized, 2-treatment, 2-period, 2-way crossover, relative bioavailability study of a capsule and a tablet formulation of XXXX in subjects with advanced solid tumors
Responsibilities:
- Counties handled: USA (4 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Autoimmune Diseases
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study of the Safety and Pharmacodynamics of XXXX in Healthy Adult Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring, and Study Closeout
- Trial Master File reconciliation
Autoimmune Diseases
A Phase 1, Single Dose, Dose-escalation Study of the Safety and Pharmacodynamics of XXXX in Healthy Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Monitoring, and Study Closeout
- Trial Master File reconciliation
Breast Cancer
A phase II, randomized, multicenter study of XXXX in patients with advanced GPNMB-expressing Breast Cancer.
Responsibilities:
- Counties handled: USA (7 sites)
- Study stage handled: Study start-up, Monitoring
- Trial Master File reconciliation
Anti-depressant
A Phase I, Randomized, Double Blind, Placebo Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of XXXX in Healthy Male and Female Volunteers
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Diabetes
A randomized, double-blind, placebo-controlled, parallel group study to investigate the effect of 150 µg XXXX once daily in healthy subjects treated with aspirin once daily on renal function, renin-angiotensin system and platelet aggregation
Responsibilities:
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up
Diabetes
A randomized, double-blind, placebo-controlled, parallel group study to investigate the effect of ibuprofen on top of multiple doses of 150 µg XXXX once daily on renal function, renin-angiotensin system, and pharmacokinetics of both compounds in healthy subjects
Responsibilities:
- Counties handled: USA (2 sites)
- Study stage handled: Study start-up
Thrombosis and Clotting Disorders
An Open-label, Randomized, Three-Period, Crossover Study to Assess the Effect of Food and Calcium on XXXX 0.25 mg Tablet Pharmacokinetics in Healthy, Adult Volunteer Subjects Following a Single 0.75 mg Oral Dose of XXXX
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Neuropathic Pain
Randomized, Single-Dose, 2-Period, 2-Sequence Crossover Food Effect Study on the Safety, Tolerability, and Pharmacokinetics of XXXX Following a 450 mg Dose in Healthy Male and Female Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring
Thrombosis and Clotting Disorders
A Phase 1, Open-Label, One-Sequence Crossover, Drug-Drug Interaction Study to Evaluate the Effect of Repeated Doses of XXXX on the Pharmacokinetics of the CYP3A4 Substrate, Midazolam, in Healthy Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Influenza
A Randomized, Open-Label, 3-Period Cross-over Drug Interaction Study of Oral XXXX With Intravenous Peramivir in Healthy Volunteers
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up
Hypertension
A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of XXXX in Subjects with Renal Impairment Compared to Matched Healthy Subjects with Normal Renal Function
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Neuropathic Pain
An Ascending Single-Dose, Single-Blind, Randomized, Placebo‑Controlled Study Assessing the Safety, Tolerability, and Pharmacokinetics of XXXX in Healthy Male Subjects
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Monitoring, Study Closeout
- Trial Master File reconciliation
Advanced Solid Tumors
A Phase 1/1b Dose Escalation Study Evaluating XXXX as a Single Agent and in Combination with XXXXX in Subjects with Advanced Solid Tumors
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Study start-up, Monitoring
- Trial Master File reconciliation
Macular Degeneration
A Phase I Open-Label, Dose Escalation Trial of XXXX Delivered by a Single Intravitreal Injection to Patients with Choroidal Neovascularization (CNV) Secondary to Exudative Age-Related Macular Degeneration (“Wet AMD”)
Responsibilities:
- Counties handled: USA (13 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Coronary Artery Disease
A Multi-centre Randomized, Double-blind, Double-dummy Parallel Group Study of the Onset and Offset of the Antiplatelet Effects of XXXX Compared with XXXXX and Placebo With Aspirin as Background Therapy in Patients with Stable Coronary Artery Disease with Additional Detailed Assessment of Cardiopulmonary Function
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Monitoring
Diabetes
A Randomized, Two Way Cross-over, Single-Blind, Phase Ι Study to Evaluate 24-hour Glucose Profiles in Patients with XXXX when Dosed OD and BD on Top of XXXX for Four Days with XXXX
Responsibilities:
- Counties handled: USA (1 site)
- Study stage handled: Monitoring
Infectious Diseases - HIV
Pharmacokinetics of XXXX During Treatment of HIV-1 Infected Subjects with Hepatic Impairment
Responsibilities:
- Counties handled: USA (3 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Urinary System
A Single Dose, Non-Randomized, Open-Label, Parallel Group Study Comparing the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of XXXX in Patients with Renal Impairment to Volunteers with Normal Renal Function
Responsibilities:
- Counties handled: USA (8 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Cystic Fibrosis
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Crossover Study to Evaluate the Effectiveness and Safety of XXXXX in Reducing Steatorrhea in Children and Adults with Cystic Fibrosis
Responsibilities:
- Counties handled: USA (3 sites)
- Study stage handled: Monitoring and Study Closeout
- Trial Master File reconciliation
Advanced Solid Tumors
A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of XXXX in Combination with Chemotherapeutic Regimens in Subjects with Advanced Solid Tumors
Responsibilities:
- Counties handled: USA (3 sites)
- Study stage handled: Study start-up, Monitoring
- Trial Master File reconciliation
Infectious Diseases - HIV
A 14-Day, Randomized, Double-Blind, Comparative Viral Kinetic Study of XXXX Versus XXXXX Administered Once Daily to HIV-1 Infected Subjects with a Documented M184V Variant
Responsibilities:
- Counties handled: USA (5 sites)
- Study stage handled: Monitoring and Study Closeout
- Trial Master File reconciliation
Opioid Therapy
A Double-Blind, Randomized, Placebo-Controlled Study of XXXX and XXXXX or XXXXX in Patients with Excessive Daytime Sleepiness Due To Opioid Therapy
Responsibilities:
- Counties handled: USA (3 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Post Operative Analgesia
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Subcutaneous or Subacromial XXXX in Patients Undergoing Rotator Cuff Repair
Responsibilities:
- Counties handled: USA (4 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Post Operative Analgesia
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Subcutaneous or Subaponeurotic XXXX in Patients Undergoing Open Inguinal Hernia Repair
Responsibilities:
- Counties handled: USA (4 sites)
- Study stage handled: Study start-up, Monitoring and Study Closeout
- Trial Master File reconciliation
Hypertension
A Phase I, Randomized, Single Dose, Four Period, Crossover Study in Healthy Male Subjects to Evaluate the Intra-Subject Variability and the Effect of Food on an Oral XXXXX Extended Release (ER) Tablet Formulation and the Relative Bioavailability of an Oral XXXXX ER Tablet Formulation Versus an Oral Immediate Release (IR) XXXXX Tablet Formulation
Thrombosis and Clotting Disorders
A Phase I Multiple-dose, Double-blind Placebo-controlled Study to Assess the Safety and Pharmacokinetics of XXXX in Healthy Subjects
Rheumatoid Arthritis
A Phase I, Open-Label, Randomized, Balanced, Two-Treatment (fasted versus fed) Crossover Trial to Investigate the Food Effect of XXXXX Administered as Single Oral Dose to Healthy Volunteers
Pain
A Phase I, Randomized, Single Dose, Five Period, Crossover Study in Healthy Subjects to Evaluate the Intra-Subject Variability of a XXXXX Extended Release (ER) Tablet Formulation Under Fasted Conditions and the Effect of Food on a XXXXX Extended Release (ER) Tablet Formulation and an Aqueous Solution of XXXXX (XXXXX) Administered Orally Under Fed and Fasted Conditions
Pain
A Phase I, Randomized, Single Dose, Four Period, Crossover Study to Evaluate the Intra-Subject Variability of a XXXXX Extended Release (ER) Tablet Formulation Administered Orally to Healthy Subjects Under Fasted Conditions
Advanced Solid Tumors
A Phase I Study of the Oral Platinum Agent XXXX in Combination with Weekly XXXXX
Bladder Cancer
Phase I Study Of XXXX And Concurrent Radiation Therapy In Patients With Muscle-Invasive Bladder Cancer Unfit For And/Or Refusing Cystectomy
Non-Small Cell Lung Cancer
Phase 2 Trial of First-Line Therapy With XXXX and XXXXX In Patients With Unresectable Stage III Or IV Non-Small Cell Lung Cancer
Non-Hematologic Cancer
A Phase I Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Safety of XXXX in Patients with Refractory Non-Hematologic Cancer
Non-Hematologic Cancer
A Phase I Study of the Effects of Renal Impairment on the Pharmacokinetics and Safety of XXXX in Patients with Refractory Non-Hematologic Cancer