GSK706769 A First Time in Human Study For Males and Females
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|