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A Study of IW-6463 in Healthy Volunteers

NCT03856827 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-08-16

No results posted yet for this study

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

DRUG

IW-6463

IW-6463 Tablet

DRUG

Matching Placebo

Matching Placebo Tablet

Sponsors & Collaborators

  • Tisento Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chad Glasser, PharmD · Cyclerion Therapeutics, Inc

  • Geert J Groeneveld, MSc · Centre for Human Drug Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2019-10-22
Completion
2019-10-22
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03856827 on ClinicalTrials.gov