drugset / Trial / 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
Non-randomizedSingle-groupOpen-labelBasic science
Summary
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.
Timeline
- Start
- 2015-05
- Primary completion
- 2015-07
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | — | Oral |
| Subject | Dextromethorphan | Unknown | — | Oral |
| Subject | Digoxin | Other / unclassified | — | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
| Subject | Omeprazole | Other / unclassified | — | Oral |
| Subject | Rolapitant | Small molecule | — | Intravenous |
| Subject | Sulfasalazine | Small molecule | — | Oral |
| Subject | Warfarin | Small molecule | — | Oral |