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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02039076
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Drug: avatrombopag Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: 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.
Drug: avatrombopag



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. 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
  2. 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.)
  3. 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.
  4. 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.
  5. Nonsmoking, healthy white and Japanese adult males and females between the ages of 20 and 55, inclusive
  6. BMI between 18 and 28. inclusive
  7. 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
  8. Males must have a vasectomy or they and their partner must use a highly effective method of contraception

Exclusion Criteria

  1. 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)
  2. Recent clinically significant illness or infection that requires medical treatment
  3. 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
  4. Any history of gastrointestinal surgery (eg, hepatectomy, nephrotomy, digestive organ resection)
  5. Any clinically abnormal symptom or organ impairment found by medical history, physical examination, vital sign electrocardiogram (ECG) assessment, or laboratory test results
  6. A known or suspected history of drug or alcohol dependency or abuse or a positive urine drug, cotinine, or alcohol test
  7. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at Screening
  8. Weight loss or gain of >10% within 4 weeks before dosing
  9. Known history of clinically significant drug or food allergy
  10. Currently enrolled in another clinical trial

Information from the National Library of Medicine

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


Locations
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United States, California
Parexel International Early Development Clinical Units
Glendale, California, United States
Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02039076    
Other Study ID Numbers: E5501-A001-018
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: November 2014
Keywords provided by Eisai Inc.:
Healthy
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases