Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
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.