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A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774773
First Posted: January 24, 2013
Last Update Posted: February 3, 2014
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.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
E5501 (5 mg, 20 mg, and 40 mg) will be administered to healthy male adults in a single-center, randomized, open-label, cross-over manner. This study will consist of 2 phases including pre-randomization (before drug administration) and postrandomization (after drug administration).

Condition Intervention Phase
Healthy Drug: Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg Drug: Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg Drug: Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet

Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

Primary Outcome Measures:
  • Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed Conditions [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose ]
  • Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] Under Fed Conditions [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

  • Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] Under Fed Conditions [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose ]
    AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).

  • Pharmacokinetic Parameter: Time to Reach Maximum Observed Plasma Concentration (Tmax) Under Fed Conditions [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose ]
  • Pharmacokinetic Parameter: Plasma Decay Half-Life (t1/2) Under Fed Conditions [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.


Enrollment: 15
Study Start Date: January 2013
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
E5501 5mg, then 20mg, then 40 mg, then 5mg
Drug: Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg

The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days.

Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.

The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively.

Experimental: Group B
E5501 20mg, then 40mg, then 5 mg, then 5mg
Drug: Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg

The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): one 5 mg tablet under fed conditions on treatment morning for 28 days.

Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.

The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively.

Experimental: Group C
E5501 40mg, then 5mg, then 20 mg, then 5mg
Drug: Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg

The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days.

Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.

The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria;

  1. Non-smokers aged 20-44 at the time of informed consent,
  2. BMI is between 18.5 kg/m2 and below 25 kg/m2 at screening,
  3. Platelet count is between 120,000/ microliter and below 300,000/ microliter at screening and baseline
  4. Subjects and their partners can agree to use medically appropriate contraception through the study period
  5. Voluntarily provided written informed consent
  6. Willing and able to comply with the protocol

Exclusion criteria;

  1. With a past or present history of arterial thrombosis, venous thrombosis or thrombophilia
  2. With a past history of clinically significant disease within 8 weeks before study drug administration or clinically significant infection within 4 weeks before study drug administration
  3. With a past surgical history that may affect the pharmacokinetics of E5501
  4. Suspected to have a clinically abnormal symptom or organ dysfunction that requires treatment based on the past history, complications, subjective and objective symptoms, vital signs and body weight, electrocardiograms or clinical laboratory results at screening or baseline
  5. QTcF greater than 450 ms (corrected for heart rate according to Fridericia's formula) category of the 12-lead electrocardiogram at screening or baseline
  Contacts and Locations
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): NCT01774773


Locations
Japan
Sumida, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Fuminori Ohba Eisai Co., Ltd.
  More Information

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01774773     History of Changes
Other Study ID Numbers: E5501-J081-015
First Submitted: January 18, 2013
First Posted: January 24, 2013
Last Update Posted: February 3, 2014
Last Verified: January 2014