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NCT02082665 · ClinicalTrials.gov registry record · Phase 1
Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02082665 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 6 participants.
The verdict
NCT02082665, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600 mutation positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of rosuvastatin and 3 mg of midazolam in the morning of Day 1 (alone), Day 8 (with first dose of dabrafenib 150 mg), and Day 22 (during repeat dose dabrafenib 150 mg twice daily \[BID\]). Dabrafenib 150 mg BID will be administered from Day 8 to Day 23. Blood samples for PK analysis will be obtained over 32 hours post-dose on Day 1, Day 8, and Day 22. The last dose of dabrafenib will be taken in the morning of Day 23 and the last blood sample in the evening of Day 23. Subjects will be considered to have completed the study once the 32 hour PK sample has been collected on Day 23. Once they have completed the study, eligible subjects may have the option to enter study BRF114144, an open-label roll-over study of dabrafenib (no follow-up visit required) and continue receiving dabrafenib.
Interventions
- DRUG Rosuvastatin10 mg tablet
- DRUG Midazolam 3 mg syrup
- DRUG Dabrafenib 75 mg capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-02-19 |
| Est. Completion | 2016-08-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02082665
The ClinicalTrials.gov registry entry for NCT02082665 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 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 3 interventions - of which Rosuvastatin10 mg tablet is the first listed.
NCT02082665 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02082665 about?
NCT02082665 is a clinical study titled "Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam". This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600 mutation positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of rosuvastatin and 3 mg of midazolam in the morning of Day 1 (alone), Day 8 (with first dose of dabrafenib 150 mg), and Day 22 ...
What is the current status of trial NCT02082665?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2015-02-19. Estimated completion is 2016-08-01.
What interventions are being tested in trial NCT02082665?
The interventions under investigation include: Rosuvastatin10 mg tablet (DRUG), Midazolam 3 mg syrup (DRUG), Dabrafenib 75 mg capsule (DRUG).
Who is sponsoring clinical trial NCT02082665?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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