CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 68 enrolled
Drug / intervention
GSK3352589 +1 moredrug
Likely dose
GSK3352589 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03154086
NCT03154086Phase 1Completed
CompareCT.gov

A Phase I, First Time in Human, Two Part, Randomized, Placebo-Controlled, Double-Blind (Sponsor Unblind), Single and Repeat Dose Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Normal Healthy Volunteers

GlaxoSmithKline·interventional·Posted May 15, 2017·Updated Aug 9, 2019

In Brief

A Phase 1 clinical trial evaluating GSK3352589 and Matching Placebo for Irritable Bowel Syndrome. Completed, enrolled 68 participants across 1 site.

Detailed Summary

This FTIH study is designed to assess the safety, tolerability and pharmacokinetic (PK) of escalating single and repeat oral doses of GSK3352589 in normal healthy volunteers. This is a randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that will have two parts; Part A and Part B.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesAustralia
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 15, 2017
Enrollment StartMay 17, 2017
Primary CompletionMar 5, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.1 years ago

Interventions

GSK3352589drug

It will be available in the dose of 1, 5, 25 and 100 mg tablet for oral administration.

Matching Placebodrug

It will be available across all strengths to match active drug in the form of tablet for oral administration.