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

NCT01290133 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2011-10-13

No results posted yet for this study

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

DRUG

GW597599

Single dose IV infusion

DRUG

Placebo

Single dose IV infusion

Sponsors & Collaborators

  • Accenture

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290133 on ClinicalTrials.gov