GSK Investigational Site
Overland Park, Kansas, 66211, United States
NCT Number: NCT01648257
This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Overland Park, Kansas, 66211, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each tablet contains 30 mg of GSK1265744 sodium salt and excipients.
Each capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients.
Each capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients.
Time frame: For 168 hours post dose (36 days)
Plasma GSK1265744 PK parameters: area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time AUC(0-infinity); AUC from time zero to time t, AUC(0-t), and maximum observed concentration, Cmax.
Time frame: For 168 hours post each dose of GSK1265744 (36 days)
Following plasma GSK1265744 PK parameters will be evaluated: concentration at 24 hour post-dose (C24), terminal phase half-life (t1/2), lag time before observation of drug concentrations in sampled matrix (tlag), time of occurrence of Cmax (tmax), percentage of AUC(0-infinity) obtained by extrapolation (%AUCex), apparent clearance following oral dosing (CL/F).
Time frame: 50 days
Time frame: 50 days
Clinical laboratory tests include hematology, clinical chemistry, urinalysis tests.
Time frame: 50 days
Time frame: 50 days
Vital sign measurements will include systolic and diastolic blood pressure and pulse rate.
Time frame: 50 days
ViiV Healthcare
Industry
A Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 in Healthy Adult 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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