Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

February 19, 2015

Primary Completion Date

July 1, 2016

Study Completion Date

August 1, 2016

Conditions
Cancer
Interventions
DRUG

Rosuvastatin10 mg tablet

Commercially available Rosuvastatin 10 mg tablets will be supplied. Single oral dose of Rosuvastatin 10 mg will be administered on Day 1, 8 and 22

DRUG

Midazolam 3 mg syrup

Commercially available Midazolam syrup will be supplied.Single oral dose of Midazolam 3 mg syrup will be administered on Days 1, 8 and 22

DRUG

Dabrafenib 75 mg capsule

Dabrafenib 75mg will be supplied in the form of capsules. Oral dose Dabrafenib 150 mg (2 x 75 mg) BID will be administered at 12 h apart on Days 8 through 22 and 150 mg (2 x 75 mg) OD on Day 23.

Trial Locations (4)

28040

GSK Investigational Site, Madrid

41013

GSK Investigational Site, Seville

03756

GSK Investigational Site, Lebanon

08035

GSK Investigational Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY