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

Post-Operative Nausea and Vomiting (PONV) Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nausea
• Post-Operative Nausea and Vomiting (PONV)
• Postoperative Nausea and Vomiting
• Vomiting

• NCT number: NCT01290133
• Study type: Interventional
• Source: Accenture
• Status: Completed
• Phase: Phase 1
• Start date: May 2011
• Completion date: October 2011