Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01340846 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01340846 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 48 participants.
The verdict
NCT01340846, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study (in 4 separate cohorts of subjects) designed to examine the interaction potential of GSK2118436, either as a perpetrator (i.e., effect of GSK2118436 on warfarin; Part A) or victim (i.e., effect of other drugs on GSK2118436; Part B: ketoconazole and Part C: gemfibrozil), as well as to evaluate the single and repeat dose pharmacokinetic parameters of GSK2118436 (Part D). A sufficient number of subjects will be screened to obtain approximately 12 evaluable subjects each for Part A, Part B, Part C and Part D. Following completion of this study, subjects may continue dosing with GSK2118436 in the roll-over study, Protocol BRF114144.
Interventions
- DRUG Warfarin
- DRUG Ketoconazole
- DRUG Gemfibrozil
- DRUG GSK2118436 150mg
- DRUG GSK2118436 75mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-09-03 |
| Est. Completion | 2012-11-14 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01340846
The ClinicalTrials.gov registry entry for NCT01340846 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Warfarin is the first listed.
NCT01340846 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01340846 about?
NCT01340846 is a clinical study titled "A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors". GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study (in 4 separate cohorts of subjects) designed to examine the interaction potential of GSK2118436, either as a per...
What is the current status of trial NCT01340846?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2012-09-03. Estimated completion is 2012-11-14.
What interventions are being tested in trial NCT01340846?
The interventions under investigation include: Warfarin (DRUG), Ketoconazole (DRUG), Gemfibrozil (DRUG), GSK2118436 150mg (DRUG), GSK2118436 75mg (DRUG).
Who is sponsoring clinical trial NCT01340846?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.