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A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors

NCT01954043 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-11-14

No results posted yet for this study

Summary

The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer) and rabeprazole (a pH elevating agent) on the PK of dabrafenib (a CYP3A4/CYP2C8 substrate). The study will be conducted in subjects with BRAF V600 mutation-positive tumors. Data collected from this study will be used to inform recommendations regarding use of concomitant medications with dabrafenib and future clinical pharmacologic evaluation of dabrafenib.

Conditions

Interventions

DRUG

Dabrafenib 150 mg twice a day (BID)

Dabrafenib dosed at 150mg twice a day from Day 1 to the morning of Day 29

DRUG

Rabeprazole 40 mg once daily (OD)

Rabeprazole dosed at 40mg each morning on Days 16 to 19

DRUG

Rifampin 600 mg OD

Rifampin dosed at 600mg each morning on Days 20 to 29

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-20
Primary Completion
2016-02-29
Completion
2016-02-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

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Entities

Diseases
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 NCT01954043 on ClinicalTrials.gov