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

A Two-Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of GSK557296 in a Randomized, Single-Blind, Placebo-Controlled, Dose-Rising Design, and to Evaluate the Effect of Food on Single Oral Doses of GSK557296 in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00549211

Enrollment

Registered

2007-10-25

Start date

2007-10-31

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labour, Premature, Premature Ejaculation

Keywords

Healthy Subjects,, Safety,, Tolerability,, Pharmacokinetics

Brief summary

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

Interventions

DRUGGSK557296

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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	24 Hours

Secondary

Measure	Time frame
Blood tests to study how long the drug stays in your blood	24 Hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026