A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Malignant Melanoma, Neoplasms
Interventions
DRUG

Rifampin

Rifampin at a dose of 600 mg as capsules orally once daily will be administered from Days 8 through 23 (Periods B and C).

DRUG

Vemurafenib

Participants, after an overnight fast of at least 10 hours, will receive vemurafenib at a dose of 960 mg as film-coated tablets orally on Day 1 (Period A) and on Day 17 (Period C).

Trial Locations (15)

324

Dakahlia

6045

Port Elizabeth

7570

Cape Town

10000

Zagreb

11796

Cairo

21131

Alexandria

42000

Varaždin

45042

Middletown

72758

Rogers

75246

Dallas

94523

Pleasant Hill

90020-090

Porto Alegre

90035-003

Porto Alegre

90840-440

Porto Alegre

Unknown

Tanta

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01765543 - A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf) | Biotech Hunter | Biotech Hunter