Clinical trial NCT01774773: A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015)
Official title: A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 15
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) Under Fed Conditions
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] Under Fed Conditions
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: Pharmacokinetic Parameter: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] Under Fed Conditions
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: Pharmacokinetic Parameter: Time to Reach Maximum Observed Plasma Concentration (Tmax) Under Fed Conditions
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: Pharmacokinetic Parameter: Plasma Decay Half-Life (t1/2) Under Fed Conditions
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Sumida
country: Japan
state: Tokyo
Study officials:
affiliation: Eisai Co., Ltd.
name: Fuminori Ohba
role: STUDY_DIRECTOR
References: