NCT03856827

A Study of IW-6463 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Tisento Therapeutics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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)

Conditions

• Other

Interventions

Type	Name	Description
DRUG	IW-6463	IW-6463 Tablet
DRUG	Matching Placebo	Matching Placebo Tablet

Timeline

• Start date: 2019-02-06
• Primary completion: 2019-10-22
• Completion: 2019-10-22
• First posted: 2019-02-27
• Last updated: 2024-08-16

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study