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
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2016-11-11
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
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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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