Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies
Status:
Completed
Trial end date:
2017-01-09
Target enrollment:
Participant gender:
Summary
The purpose of this study is to characterize the pharmacokinetics (PK) of a single
intravenous (IV) infusion of 14C-labeled vemurafenib administered shortly after an oral dose
of vemurafenib and following multiple oral doses of vemurafenib twice daily (BID) at steady
state as well as to estimate the absolute bioavailability of multiple oral doses of
vemurafenib BID at steady state in participants with BRAF^V600 mutation-positive
malignancies. The study has two periods: Period A and Period B. During Period A, participants
will receive vemurafenib BID orally from Day 1 to Day 20 and during Period B, participants
will receive single IV infusion of 14C-labeled vemurafenib along with vemurafenib BID oral
dose.