GSK706769 A First Time in Human Study For Males and Females
|ClinicalTrials.gov Identifier: NCT00539201|
Recruitment Status : Terminated
First Posted : October 4, 2007
Last Update Posted : October 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Drug: GSK706769||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
- 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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539201
|United States, Wisconsin|
|GSK Investigational Site|
|Madison, Wisconsin, United States, 53704|
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|