GSK Investigational Site
Buffalo, New York, 14202, United States
NCT Number: NCT00812318
To evaluate the single dose relative bioavailability of GSK1265744 10mg administered in either oral solution fasted, two 5mg tablets fasted, or two 5mg tablets following a moderate meal.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Buffalo, New York, 14202, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: 1 drink is equivalent to 12 g alcohol = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Note: This does not include plasma donation.
Note: "Study" or "investigational" drugs include GSK1265744 or placebo.
GSK1265744
Other names: GSK1265744
GSK1265744 5mg tablet, fasted
Other names: GSK1265744
Time frame: 6 days
Plasma GSK1265744 Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)], Area under the concentration-time curve over the dosing interval [AUC(0-t)], and Maximum observed concentration (Cmax).
Time frame: 6 days
Time frame: 6 days
Plasma GSK1265744 Terminal phase half-life (t½), Lag time before observation of drug concentrations in sampled matrix (tlag), Time of occurrence of Cmax (tmax), and Apparent clearance following oral dosing (CL/F).
Time frame: 6 days
Clinical chemistry, hematology and urinalysis compared to baseline values
Time frame: 6 days
Time frame: 6 days
Time frame: 6 days
blood pressure and heart rate
ViiV Healthcare
Industry
A Single Dose, Randomized Study to Assess the Relative Bioavailability of Two Formulations and Food Effect on GSK1265744 in Healthy Male and Female Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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