A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Malignant Melanoma, Neoplasms
Interventions
DRUG

Digoxin

Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.

DRUG

Vemurafenib

Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35.

Trial Locations (13)

2193

Johannesburg

31096

Haifa

52661

Tel Litwinsky

115478

Moscow

197758

Saint Petersburg

223040

Minsk District

420029

Kazan'

6423906

Tel Aviv

BU-220013

Minsk

BU-210603

Vitebsk

702-911

Daegu

110-774

Seoul

135-710

Seoul

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01765569 - A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma | Biotech Hunter | Biotech Hunter