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

GlaxoSmithKline42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstetric Labour, Premature Premature Ejaculation

Interventions

GSK557296DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Evansville, Indiana, United States

Outcomes

Primary Outcomes

Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs

Time frame: 24 Hours

Secondary Outcomes

Blood tests to study how long the drug stays in your blood

Time frame: 24 Hours

Data from ClinicalTrials.gov

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