A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
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
1 other identifier
interventional
42
1 country
1
Brief Summary
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 23, 2007
CompletedFirst Posted
Study publicly available on registry
October 25, 2007
CompletedMarch 19, 2012
February 1, 2011
October 23, 2007
March 15, 2012
Conditions
Keywords
Outcome Measures
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
24 Hours
Secondary Outcomes (1)
Blood tests to study how long the drug stays in your blood
24 Hours
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Evansville, Indiana, 47714, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2007
First Posted
October 25, 2007
Study Start
October 1, 2007
Last Updated
March 19, 2012
Record last verified: 2011-02