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

NCT ID: NCT01774773

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-08-31

Brief Summary

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

E5501 5mg, then 20mg, then 40 mg, then 5mg

Group Type: EXPERIMENTAL

Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg

Intervention Type: DRUG

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.

Group B

E5501 20mg, then 40mg, then 5 mg, then 5mg

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Group C

E5501 40mg, then 5mg, then 20 mg, then 5mg

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fuminori Ohba

Role: STUDY_DIRECTOR

Eisai Co., Ltd.

Locations

Sumida City, Tokyo, Japan

Countries

Japan

Other Identifiers

E5501-J081-015

Identifier Type: -

Identifier Source: org_study_id