A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects

Phase 1

Completed

• Conditions: Thrombocytopenia
• Interventions: Drug: avatrombopag

• Registration Number: NCT02039076
• Lead Sponsor: Eisai Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-17
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
avatrombopag	avatrombopag	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) profiles of avatrombopag	Up to 23 Weeks	The following PK parameters will be estimated for plasma: Cmax, AUC, and t1/2.

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic (PD) profiles of avatrombopag	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	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	Up to 23 Weeks	Saftey assessments include AEs, clinical laboratory results, vital signs, and ECGs.
Laboratory assessments as a measure of safety and tolerability	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	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	Up to 23 Weeks	Twelve-lead ECGs will be obtained as a measure of safety and tolerability

Trial Locations

Locations (1)

Parexel International Early Development Clinical Units; 🇺🇸 Glendale, California, United States