Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| avatrombopag | Experimental | Each subject will receive a single administration during each of the 5 treatment periods as follows: 40 and 60 mg in the fed and fasted state, and 20 mg in the fed state. Subjects will be randomized to one of four dosing sequences. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| avatrombopag | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profiles of avatrombopag | The following PK parameters will be estimated for plasma: Cmax, AUC, and t1/2. | Up to 23 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 23 Weeks |
| Comparison of PK and PD for avatrombopag |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International Early Development Clinical Units | Glendale | California | United States |
Not provided
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| C533238 | avatrombopag |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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. | 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 | 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 | 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 | Up to 23 Weeks |