An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

July 31, 2015

Study Completion Date

August 31, 2015

Conditions
Chemotherapy-induced Nausea and Vomiting
Interventions
DRUG

Rolapitant

DRUG

Digoxin

P-gp substrate

DRUG

Sulfasalazine

BCRP substrate

DRUG

Cooperstown Cocktail

Midazolam, omeprazole, warfarin, caffeine, and dextromethorphan

Trial Locations (1)

21225

Parexel Early Phase Unit, Baltimore

All Listed Sponsors
lead

Tesaro, Inc.

INDUSTRY

NCT02434861 - An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects | Biotech Hunter | Biotech Hunter