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

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg; Drug: Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg; Drug: Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01774773

E5501-J081-015

Details and patient eligibility

About

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).

Enrollment: 15 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Group A

Experimental group

Description:

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

Treatment:

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

Group B

Experimental group

Description:

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

Treatment:

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

Group C

Experimental group

Description:

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

Treatment:

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