Back to resultsA First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
Primary Purpose
Obstetric Labour, Premature, Premature Ejaculation
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK557296
Sponsored by
About this trial
This is an interventional treatment trial for Obstetric Labour, Premature focused on measuring Healthy Subjects,, Safety,, Tolerability,, Pharmacokinetics
Eligibility 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
Sites / Locations
- GSK Investigational Site
Outcomes
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
Secondary Outcome Measures
Blood tests to study how long the drug stays in your blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00549211
Brief Title
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labour, Premature, Premature Ejaculation
Keywords
Healthy Subjects,, Safety,, Tolerability,, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK557296
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Blood tests to study how long the drug stays in your blood
Time Frame
24 Hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
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