A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of IW-6463 When Administered to Healthy Volunteers as Single Ascending Doses, as Multiple Ascending Doses, and Under Fed Versus Fasting Conditions

C6463-101

Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)

2019-02-06

2019-10-22

2019-10-22

Completed

Early phase I

110

Inclusion Criteria: * Subject is an ambulatory adult between 18 and 64 years old at the screening visit with the exception of the elderly cohort, who must be 65 years or older at the screening visit. * Subject is in good health and has no clinically significant findings on physical examination * Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 3 months after the final dose of study drug * Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 3 months after the final dose of study drug * Other inclusion criteria per protocol Exclusion Criteria: * Any active or unstable clinically significant medical condition * Use of any prescribed or non-prescribed medication * Other exclusion criteria per protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}

2023-10-17