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
Public ClinicalTrials.gov record NCT01340846. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose GSK2118436 on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of GSK2118436, and the Repeat Dose Pharmacokinetics of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01340846
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Interventions
- Warfarin Drug
- Ketoconazole Drug
- Gemfibrozil Drug
- GSK2118436 150mg Drug
- GSK2118436 75mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2, 2012
- Primary completion
- Nov 13, 2012
- Completion
- Nov 13, 2012
- Last update posted
- Nov 12, 2017
2012
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Scottsdale | Arizona | 85259 | — |
| GSK Investigational Site | Sarasota | Florida | 34232 | — |
| GSK Investigational Site | Detroit | Michigan | 48201 | — |
| GSK Investigational Site | Columbus | Ohio | 43210 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | — |
| GSK Investigational Site | Greenville | South Carolina | 29605 | — |
| GSK Investigational Site | Nashville | Tennessee | 37203 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01340846, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 12, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01340846 live on ClinicalTrials.gov.