GSK706769 A First Time in Human Study For Males and Females
This study has been terminated.
Information provided by:
First received: October 2, 2007
Last updated: October 13, 2010
Last verified: October 2010
To determine safety, tolerability and pharmacokinetics of GSK706769
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single and Repeat Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GSK706769 in Healthy Male and Female Subjects|
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Blood levels of drug [ Time Frame: over 48 hours or 14 days. ]
- Laboratory test results [ Time Frame: over 48 hours or 14 days ]
- Vital signs [ Time Frame: over 48 hours or 14 days ]
Secondary Outcome Measures:
- Effect of food on blood levels of drug [ Time Frame: over 48 hours ]
- Effect of Kaletra on blood levels of drug [ Time Frame: over 48 hours ]
- Effect of midazolam on drug levels [ Time Frame: over 12 hours ]
- Plasma GSK706769 PK parameters, AUC(0-∞) or AUC(0-t), Cmax, tmax and tlag following single dose administration of a given dose of GSK706769 with and without high fat/calorie meal.
- Plasma GSK706769 PK parameters, AUC(0-∞), AUC(0-t), Cmax, C12, and t1/2 following a single dose of GSK706769 with and without a single dose of LPV/RTV 400/100mg.
- Safety parameters during LPV/RTV 400mg/100mg or high fat/calorie meal
- Plasma AUC(0-∞) and CL/F of midazolam, a surrogate estimate of CYP3A enzyme activity, with and without GSK706769 co-administration.
- Plasma GSK706769 PK parameters, AUC(0-∞) or AUC(0-t), Cmax, tmax and tlag, following single oral dose administered as tablet and solution.
- Percentage and rate of change in CCR5 RO.
- Day 14 GSK706769 AUC(0-τ) compared to Day 1 AUC(0-12) (if BID dosing) or Day 1 AUC(0-24) (if QD dosing) to estimate accumulation ratio (R) and GSK706769 AUC(0-τ) on Day 14 compared to AUC(0-∞) on Day 1 to evaluate time invariance
- Pre-morning dose concentrations (Cτ) on Day 2 through 14 to assess the achievement of steady state of GSK706769 following repeat administration.
- GSK706769 PK parameters: AUC(0-∞), AUC(0-t), and Cmax following single dose administration and AUC(0-τ), Cτ, and Cmax following repeat administration at different doses for the assessment of dose proportionality.
|Study Start Date:||September 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Other Name: GSK706769
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