A Study of IW-6463 in Healthy Volunteers

Phase 1

Completed

• Conditions: Other
• Interventions: Drug: IW-6463; Drug: Matching Placebo

• Registration Number: NCT03856827
• Lead Sponsor: Tisento Therapeutics

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-06
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-27
• Primary Completion: 2019-10-22
• Study Completion: 2019-10-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IW-6463	IW-6463	IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food
Placebo	Matching Placebo	Matching placebo tablets administered orally

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Centre for Human Drug Research; 🇳🇱 Leiden, Netherlands