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NCT02434861 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Tesaro.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
NCT02434861: Completed Phase 1 study, sponsored by Tesaro.
NCT02434861 is a Phase 1 study that has completed, run by Tesaro. The registered enrollment target is 102 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02434861, a Phase 1 study, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
Study 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.
Primary Outcome
To evaluate the effect of Rolapitant on the PK of probe substrates
Interventions
- DRUG Sulfasalazine
- DRUG Digoxin
- DRUG Rolapitant
- DRUG Cooperstown Cocktail
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-05 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT02434861 record still lists
NCT02434861 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher).
The record links to 0 conditions, and to 4 interventions - of which Sulfasalazine is the first listed.
NCT02434861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02434861 about?
NCT02434861 is a clinical study titled "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". 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.
What is the current status of trial NCT02434861?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2015-05. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02434861?
The interventions under investigation include: Sulfasalazine (DRUG), Digoxin (DRUG), Rolapitant (DRUG), Cooperstown Cocktail (DRUG).
Who is sponsoring clinical trial NCT02434861?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02434861's enrollment target sits among peer trials
102 543rd of 2000 higher than 1,455 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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