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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg of GSK3179106 QD-Cohort 1 | Experimental | Eligible six subjects will receive 10 mg oral dose once daily for 14 days |
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| 50 mg of GSK3179106 QD-Cohort 2 | Experimental | Eligible six subjects will receive 50 mg oral dose once daily for 14 days |
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| 200 mg of GSK3179106 QD-Cohort 3 | Experimental | Eligible six subjects will receive 200 mg oral dose once daily for 14 days |
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| 400 mg of GSK3179106 QD-Cohort 4 | Experimental | Eligible six subjects will receive 400 mg oral dose once daily for 14 days |
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| 25 mg of GSK3179106 BID-Cohort 5 | Experimental | Eligible six subjects will receive 25 mg oral dose twice daily for 14 days |
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| 200 mg of GSK3179106 BID-Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3179106 | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse event (AE) | 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 | Up to Day 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30277655 | Derived | Cooper M, O'Connor-Semmes R, Reedy BA, Hacquoil K, Gorycki P, Pannullo K, Verticelli A, Shakib S. 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 Dev. 2019 Feb;8(2):234-245. doi: 10.1002/cpdd.600. Epub 2018 Sep 13. |
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Eligible six subjects will receive 200 mg oral dose twice daily for 14 days
|
| Matching placebo QD-Cohort 1, 2, 3, 4 | Placebo Comparator | Eligible two subjects, per cohort, will receive oral dose of matched placebo once daily for 14 days |
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| Matching placebo BID-Cohort 5, 6 | Placebo Comparator | Eligible two subjects, per cohort, will receive oral dose of matched placebo twice daily for 14 days |
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| Matched Placebo | Drug | 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 |
|
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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