NCT02382666

A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of single increasing doses of intravenously administered rolapitant in healthy male and female subjects.

Detailed description

Part 1 of the study is designed to evaluate the safety and tolerability of a SAD, up to 6 cohorts,of rolapitant IV (2 mg/mL solution) administered as an IV infusion over 30 minutes. In Part 2 of the study, the safety and tolerability of the highest safe and well-tolerated dose established in Part 1 will be evaluated in an expanded cohort. The highest safe and well-tolerated dose established in Part 1 will be ascertained by the following criteria: an upper limit of 90% confidence interval (CI) for Cmax. A minimum of 40 subjects will be enrolled in Part 2.

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Rolapitant

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-03-09
• Last updated: 2015-08-25

Locations

1 site across 1 country: United States