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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

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ClinicalTrials.gov Identifier: NCT02798991
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: GSK3179106 Drug: Matched Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: 10 mg of GSK3179106 QD-Cohort 1
Eligible six subjects will receive 10 mg oral dose once daily for 14 days
Drug: GSK3179106
It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

Experimental: 50 mg of GSK3179106 QD-Cohort 2
Eligible six subjects will receive 50 mg oral dose once daily for 14 days
Drug: GSK3179106
It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

Experimental: 200 mg of GSK3179106 QD-Cohort 3
Eligible six subjects will receive 200 mg oral dose once daily for 14 days
Drug: GSK3179106
It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

Experimental: 400 mg of GSK3179106 QD-Cohort 4
Eligible six subjects will receive 400 mg oral dose once daily for 14 days
Drug: GSK3179106
It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

Experimental: 25 mg of GSK3179106 BID-Cohort 5
Eligible six subjects will receive 25 mg oral dose twice daily for 14 days
Drug: GSK3179106
It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

Experimental: 200 mg of GSK3179106 BID-Cohort 6
Eligible six subjects will receive 200 mg oral dose twice daily for 14 days
Drug: GSK3179106
It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

Placebo Comparator: Matching placebo QD-Cohort 1, 2, 3, 4
Eligible two subjects, per cohort, will receive oral dose of matched placebo once daily for 14 days
Drug: Matched Placebo
It is uncoated round or oblong placebo tablet prepared to match actives across all strengths. It is White to slightly colored tablet and will be administered orally

Placebo Comparator: Matching placebo BID-Cohort 5, 6
Eligible two subjects, per cohort, will receive oral dose of matched placebo twice daily for 14 days
Drug: Matched Placebo
It is uncoated round or oblong placebo tablet prepared to match actives across all strengths. It is White to slightly colored tablet and will be administered orally




Primary Outcome Measures :
  1. Number of subjects with adverse event (AE) [ Time Frame: Up to Day 25 ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798991


Locations
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Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02798991     History of Changes
Other Study ID Numbers: 205181
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by GlaxoSmithKline:
REarranged during Transfection Growth Factor Receptor Tyrosine Kinase Inhibitor
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases