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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00549211
First received: October 23, 2007
Last updated: March 15, 2012
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Obstetric Labour, Premature
Premature Ejaculation
Drug: GSK557296
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Blood tests to study how long the drug stays in your blood [ Time Frame: 24 Hours ]

Estimated Enrollment: 42
Study Start Date: October 2007
Intervention Details:
    Drug: GSK557296
    Other Name: GSK557296
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549211

Locations
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00549211     History of Changes
Other Study ID Numbers: OTB109039
Study First Received: October 23, 2007
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Healthy Subjects,
Safety,
Tolerability,
Pharmacokinetics

Additional relevant MeSH terms:
Obstetric Labor, Premature
Sexual Dysfunctions, Psychological
Obstetric Labor Complications
Pregnancy Complications
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014