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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Premature Ejaculation
Genital Diseases, Male
Mental Disorders
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on November 19, 2014