Last updated: 07/31/2020 03:00:22

A phase I, randomized, placebo-controlled, double blind, repeat dose escalation study to evaluate the safety, tolerability, pharmacokinetics, gastrointestinal transit time and pharmacodynamic biomarkers of GSK3179106 in normal subjects

GSK study ID
205181
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Clinicaltrials.gov ID
NCT02798991
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of subjects with adverse event (AE)

Timeframe: Up to Day 25

Secondary outcomes:
Not applicable
Interventions:
  • Drug: GSK3179106
  • Drug: Matched Placebo
    • Enrollment:
    46
    Primary completion date:
    2016-11-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Melisa Cooper, Robin O’Connor-Semmes, Beth Ann Reedy, Kimberley Hacquoil, Peter Goryck, Kirsten Pannullo, Adeline Verticelli, Sepehr Shakib.First in Human Studies for a Selective RET Tyrosine Kinase Inhibitor, GSK3179106, to Investigate the Safety, Tolerability and Pharmacokinetics in Healthy Volunteers.Clin Pharmacol Drug Devel.2018;8(2):234-245 DOI: 10.1002/cpdd.600 PMID: 30277655
    Medical condition
    Irritable Bowel Syndrome
    Product
    GSK3179106
    Collaborators
    Not applicable
    Study date(s)
    June 2016 to November 2016
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
    • Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. History of regular bowel habits
    • ALT and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1. ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
    • Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. History of regular bowel habits
    • Male or Female of non-childbearing potential.
    • Capable of giving signed informed consent which includes compliance with the requirements and restrictions
    Exclusion criteria:
    • ALT and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1. ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    • Estimated Glomerular Filtration Rate <60 milliliter per minute per 1.73 square meter (mL/min/1.73m^2)
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
    • History of Gastroesophageal reflux disease (GERD), dyspepsia, GI bleeding, GI surgery that could affect motility

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Adelaide, South Australia, Australia, 5000
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
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    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2016-11-11
    Actual study completion date
    2016-11-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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