- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00549211
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
March 15, 2012 updated by: GlaxoSmithKline
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
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Evansville, Indiana, United States, 47714
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: 24 Hours
|
24 Hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood tests to study how long the drug stays in your blood
Time Frame: 24 Hours
|
24 Hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Study Registration Dates
First Submitted
October 23, 2007
First Submitted That Met QC Criteria
October 23, 2007
First Posted (Estimate)
October 25, 2007
Study Record Updates
Last Update Posted (Estimate)
March 19, 2012
Last Update Submitted That Met QC Criteria
March 15, 2012
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OTB109039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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