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

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT01954043
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib 150 mg twice a day (BID) — DRUG
    Dabrafenib dosed at 150mg twice a day from Day 1 to the morning of Day 29
  • Rabeprazole 40 mg once daily (OD) — DRUG
    Rabeprazole dosed at 40mg each morning on Days 16 to 19
  • Rifampin 600 mg OD — DRUG
    Rifampin dosed at 600mg each morning on Days 20 to 29

Study Details

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.

Key Dates

Start date
Dec 20, 2013
Status verified
Nov 2017
Primary completion
Feb 29, 2016
Completion
Feb 29, 2016

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Subjects will administer Dabrafenib from Day 1 to Day 15, Dabrafenib and Rabeprazole from Day 16 to Day 19, Dabrafenib and Rifampin from Day 20 to Day 29. The serial PK samples will be collected for 12 hours following dosing on Day 15 (Dabrafenib alone), Day 19 (Dabrafenib and Rabeprazole), and Day 29 (Dabrafenib and Rifampin).

Primary Outcome Measure

PK assessment (Cmax) of Dabrafenib with and without Rabeprazole or Rifampin [ Time Frame: Day 15, 19 and Day 29 ]

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteGoodyearArizona85338-
GSK Investigational SiteDallasTexas75201-
GSK Investigational SiteTacomaWashington98405-

Find similar trials in Goodyear, AZ

By research site
GSK Investigational Site· Goodyear, AZGSK Investigational Site· Dallas, TXGSK Investigational Site· Tacoma, WA

Related Studies