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Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies

NCT02441465 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-11-14

No results posted yet for this study

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.

Conditions

  • Malignant Melanoma, Cancer

Interventions

DRUG

Vemurafenib

Oral vemurafenib will be administered at a dose of 960 milligrams BID from Day 1 to Day 28.

DRUG

14C-Labeled Vemurafenib

IV infusion of 18.5 kilobecquerel (kBq) of 14C-labeled vemurafenib (3 milliliters \[mL\], which corresponds to a dose of 20 micrograms \[mcg\] of vemurafenib) on Day 21 (immediately after the morning oral dose of vemurafenib).

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-13
Primary Completion
2016-08-18
Completion
2017-01-09

Countries

  • Hungary

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02441465 on ClinicalTrials.gov