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

NCT02039076 | Completed Phase 1

• 1 other identifier: E5501-A001-018
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombocytopenia

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic (PK) profiles of avatrombopag

  The following PK parameters will be estimated for plasma: Cmax, AUC, and t1/2.

  Up to 23 Weeks

Secondary Outcomes (6)

• Pharmacodynamic (PD) profiles of avatrombopag

  Up to 23 Weeks

• Comparison of PK and PD for avatrombopag

  Up to 23 Weeks

• Adverse events (AEs ) as a measure of safety and tolerability

  Up to 23 Weeks

• Laboratory assessments as a measure of safety and tolerability

  Up to 23 Weeks

• Vital signs as a measure of safety and tolerability

  Up to 23 Weeks

Study Arms (1)

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.

Drug: avatrombopag

Interventions

avatrombopag DRUG

avatrombopag

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Platelet count between the lower limit of normal and 350 x 109/L, inclusive, at Screening and each Baseline; measurements can repeated for verification, if necessary
• Nonsmoking, healthy white and Japanese adult male and female subjects, greater than or equal to 20 years and less than or equal to 55 years old at the time of informed consent. (Nonsmokers are defined as those who have discontinued smoking for at least 4 weeks before dosing.)
• Japanese subjects must be born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their lifestyle or habits, including diet, while living outside of Japan.
• Body mass index greater than or equal to 18 and less than or equal to 28 kg/m2 at Screening and Baseline Period 1. The BMI in white subjects must be within +/- 2 kg/m2 of the BMI in Japanese subjects.
• Nonsmoking, healthy white and Japanese adult males and females between the ages of 20 and 55, inclusive
• BMI between 18 and 28. inclusive
• Females must not be pregnant or lactating, and if they are of childbearing potential they must agree to use a highly effective method of contraception or abstain
• Males must have a vasectomy or they and their partner must use a highly effective method of contraception

You may not qualify if:

• Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history (eg, history of splenectomy); history of arterial or venous thrombosis, including partial or complete thromboses (eg, stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, pulmonary embolism); known family history of hereditary thrombophilic disorders (eg, Factor V Leiden, antithrombin III deficiency)
• Recent clinically significant illness or infection that requires medical treatment
• Evidence of disease that may influence the outcome of the study (eg, psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system), or subjects who have a congenital abnormality in metabolism
• Any history of gastrointestinal surgery (eg, hepatectomy, nephrotomy, digestive organ resection)
• Any clinically abnormal symptom or organ impairment found by medical history, physical examination, vital sign electrocardiogram (ECG) assessment, or laboratory test results
• A known or suspected history of drug or alcohol dependency or abuse or a positive urine drug, cotinine, or alcohol test
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at Screening
• Weight loss or gain of \>10% within 4 weeks before dosing
• Known history of clinically significant drug or food allergy
• Currently enrolled in another clinical trial

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Parexel International Early Development Clinical Units

Glendale, California, United States

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 17, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-11

Locations

US (1)