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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774773
• Other study ID #: E5501-J081-015
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2013
• Last updated: January 31, 2014
• Start date: January 2013
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed Conditions		0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] Under Fed Conditions	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)	0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] Under Fed Conditions	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).	0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Pharmacokinetic Parameter: Time to Reach Maximum Observed Plasma Concentration (Tmax) Under Fed Conditions		0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose	No
Primary	Pharmacokinetic Parameter: Plasma Decay Half-Life (t1/2) Under Fed Conditions	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose	No