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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
GSK Investigational Site
Overland Park, Kansas, United States
Composite of PK parameters following single oral dose administration of GSK1265744
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 dose (36 days)
Composite of PK parameters following single oral dose administration of GSK1265744
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: For 168 hours post each dose of GSK1265744 (36 days)
Safety and tolerability as assessed by the collection of adverse events
Time frame: 50 days
Safety and tolerability as assessed by change from baseline in clinical laboratory tests
Clinical laboratory tests include hematology, clinical chemistry, urinalysis tests.
Time frame: 50 days
Safety and tolerability as assessed by change from baseline in electrocardiogram (ECG)
Time frame: 50 days
Safety and tolerability as assessed by change from baseline in vital signs
Vital sign measurements will include systolic and diastolic blood pressure and pulse rate.
Time frame: 50 days
Safety and tolerability as assessed by the collection of concurrent medication.
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Time frame: 50 days