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
Completed · Phase 1
Conditions studied: Chemotherapy-induced Nausea and Vomiting
In brief
The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy adult population.
Key facts
- Study ID
- NCT02434861
- Run by
- Tesaro, Inc.
- People needed
- 102
- Starts
- 2015-05-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2015-08-25
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
Where it is running
- Parexel Early Phase Unit — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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