This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of avatrombopag following a single administration of avatrombopag in the fed and fasted condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat, high calorie breakfast will be used to assess the fed condition.
The study will comprise a Prerandomization Phase and a Randomization Phase. The Prerandomization Phase will include 2 periods, Screening and Baseline 1. The Screening Period will be up to 3 weeks (21 days) in duration. The Randomization Phase will consist of 5 single-dose treatment periods, of which 3 will include administration of avatrombopag in the fed condition and 2 will include administration of avatrombopag in the fasted condition. Each treatment period will be separated by a wash out interval of at least 28 days. Before each treatment period, subjects will complete a baseline period (Baseline Periods 2, 3, 4, and 5), during which baseline assessments will be collected. A Final Visit will occur 28 days (+/- 1 day) after dosing in Treatment Period 5.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Parexel International Early Development Clinical Units
Glendale, California, United States
Pharmacokinetic (PK) profiles of avatrombopag
The following PK parameters will be estimated for plasma: Cmax, AUC, and t1/2.
Time frame: Up to 23 Weeks
Pharmacodynamic (PD) profiles of avatrombopag
Analyses will carried out for AUEC(0-28d) and Emax using a mixed linear model including fixed terms for dose, race, food, sequence, and period with interaction terms for food by race and for dose by race and subject as random effect.
Time frame: Up to 23 Weeks
Comparison of PK and PD for avatrombopag
To assess the similarity of the PK and PD of avatrombopag between healthy Japanese and white subjects after a single administration of avatrombopag under fasted conditions
Time frame: Up to 23 Weeks
Adverse events (AEs ) as a measure of safety and tolerability
Saftey assessments include AEs, clinical laboratory results, vital signs, and ECGs.
Time frame: Up to 23 Weeks
Laboratory assessments as a measure of safety and tolerability
Clinical laboratory assessments will include haematology, clinical chemistry, urinalysis and other screening tests
Time frame: Up to 23 Weeks
Vital signs as a measure of safety and tolerability
Vital sign measurements will include systolic and diastolic blood pressure (BP) and pulse rate
Time frame: Up to 23 Weeks
Electrocardiogram (ECG) as a measure of safety and tolerability
Twelve-lead ECGs will be obtained as a measure of safety and tolerability
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Time frame: Up to 23 Weeks