A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.

NCT ID: NCT00549211

Last Updated: 2012-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.

Detailed Description

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Conditions

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Obstetric Labour, Premature Premature Ejaculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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GSK557296

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males who are 18 to 45 years of age
* Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician
* Non-smokers

Exclusion Criteria

* Alcohol consumption averaging more than 7 drinks per week
* Positive for Hepatitis C antibody, Hepatitis B antigen or HIV
* Any use of prescription drugs or non prescription drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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OTB109039

Identifier Type: -

Identifier Source: org_study_id

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