GSK1349572 First Time in Human Study
This study has been completed.
Information provided by:
First received: November 5, 2007
Last updated: October 13, 2010
Last verified: October 2010
To determine safety, tolerability and pharmacokinetics of GSK1349572
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1349572 in Healthy Subjects|
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Blood levels of drug over 72 hours. Laboratory test results over 72 hours Vital signs, ECG results over 72 hours [ Time Frame: 72 hours. ]
Secondary Outcome Measures:
- Dose proportionality over 72 hours [ Time Frame: 72 hours. ]
- GSK1349572 PK parameters: absorption lag time (tlag), and apparent clearance (CL/F) following single dose administration.
- AUC(0-¥), AUC(0-t), Cmax, and C24 following single dose administration at different doses for the assessment of dose proportionality.
|Study Start Date:||November 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Other Name: GSK1349572
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