A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects
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|ClinicalTrials.gov Identifier: NCT02039076|
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : December 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Thrombocytopenia||Drug: avatrombopag||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||September 2014|
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.
- Pharmacokinetic (PK) profiles of avatrombopag [ Time Frame: Up to 23 Weeks ]The following PK parameters will be estimated for plasma: Cmax, AUC, and t1/2.
- Pharmacodynamic (PD) profiles of avatrombopag [ Time Frame: Up to 23 Weeks ]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.
- Comparison of PK and PD for avatrombopag [ Time Frame: Up to 23 Weeks ]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
- Adverse events (AEs ) as a measure of safety and tolerability [ Time Frame: Up to 23 Weeks ]Saftey assessments include AEs, clinical laboratory results, vital signs, and ECGs.
- Laboratory assessments as a measure of safety and tolerability [ Time Frame: Up to 23 Weeks ]Clinical laboratory assessments will include haematology, clinical chemistry, urinalysis and other screening tests
- Vital signs as a measure of safety and tolerability [ Time Frame: Up to 23 Weeks ]Vital sign measurements will include systolic and diastolic blood pressure (BP) and pulse rate
- Electrocardiogram (ECG) as a measure of safety and tolerability [ Time Frame: Up to 23 Weeks ]Twelve-lead ECGs will be obtained as a measure of safety and tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039076
|United States, California|
|Parexel International Early Development Clinical Units|
|Glendale, California, United States|