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NCT02798991

A Phase I, 14 Day, Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Repeat Dose, Ascending Cohort Study to Evaluate the Safety, Tolerability Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Normal Healthy Volunteers

Completed Phase 1 Last updated 16 January 2017
What this trial tests

Phase 1 trial testing GSK3179106 in Irritable Bowel Syndrome in 46 participants. Completed in 1 November 2016.

Timeline
1 June 2016
Primary endpoint
1 November 2016
1 November 2016

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment46
Start date1 June 2016
Primary completion1 November 2016
Estimated completion1 November 2016
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Irritable Bowel Syndrome. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized, double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. First-in-Human Studies for a Selective RET Tyrosine Kinase Inhibitor, GSK3179106, to Investigate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers.
    Cooper M, O'Connor-Semmes R, Reedy BA, Hacquoil K, et al · · 2019 · cited 1× · PMID 30277655 · DOI 10.1002/cpdd.600

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Other trials of GSK3179106

Trials testing the same drug.

Other recruiting trials for Irritable Bowel Syndrome

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing