A Study of IW-6463 in Healthy Volunteers

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Other

Intervention / Treatment
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* Drug: IW-6463
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IW-6463<br>IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food | Drug: IW-6463<br>* IW-6463 Tablet<br>|
| Placebo Comparator: Placebo<br>Matching placebo tablets administered orally | Drug: Matching Placebo<br>* Matching Placebo Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) in the IW-6463 dose-level cohorts vs the (pooled) placebo group. |  | Up to 9 days | 
| After multiple ascending doses, number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the (pooled) placebo group. |  | Up to 32 days | 
| After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period |  | Up to 28 days | 
| Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions |  | Up to 21 days |