NCT02285647

An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence study of orally- and IV-administered rolapitant in healthy male and female subjects.

Detailed description

To assess the bioequivalence of a single oral dose of 200 mg rolapitant and a single intravenous dose of 185 mg rolapitant administered as an infusion.

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Rolapitant - Oral	Oral Treatment A Investigational Product: Rolapitant Dose: 200 mg (4 x 50 mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight)
DRUG	Rolapitant - IV	IV Treatment B Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight)

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2014-11-07
• Last updated: 2015-08-25

Locations

1 site across 1 country: United States