NCT01290133

Single Dose Safety Study for Compound to Treat Post-Operative Nausea and Vomiting (PONV)

A Phase I, Randomized, Placebo-Controlled, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of the Captisol™ Formulation of Vestipitant (GW597599) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Accenture · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to describe the safety and tolerability and pharmacokinetics of a single intravenous administration of the new, Sulfobutyl Ether-7-Beta-Cyclodextrin (Captisol™) based, formulation in Healthy Adult Subjects.

Conditions

• Post-Operative Nausea and Vomiting (PONV)

Interventions

Type	Name	Description
DRUG	GW597599	Single dose IV infusion
DRUG	Placebo	Single dose IV infusion

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-02-04
• Last updated: 2011-10-13

Locations

1 site across 1 country: Australia