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CompletedNCT00549211Updated Mar 19, 2012

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

A Phase 1 interventional study of GSK557296 in Obstetric Labour, Premature and Premature Ejaculation, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-19.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Obstetric Labour, Premature
  • Premature Ejaculation

Keywords

  • Healthy Subjects,
  • Safety,
  • Tolerability,
  • Pharmacokinetics
03

In context

Premature Birth

2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 42 is below the median of 84 across 1,688 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
42 participants (estimated)

Interventions

  • DrugGSK557296
06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: 24 Hours

07

Study locations

1 site
  • GSK Investigational Site
    Evansville, Indiana 47714, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00549211
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 25, 2007
Start date
Oct 2007
Last update
Mar 19, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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