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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 is a Phase 1 study that has completed, run by Tesaro. The registered enrollment target is 102 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02434861
The ClinicalTrials.gov registry entry for NCT02434861 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sulfasalazine is the first listed.
NCT02434861 reports 0 study locations.
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.
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