Healthy adult
Conditions
Interventions
investigational material(s)
Generic name etc : E5501
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigationa
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion 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 120000/microliter and below 300000/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 cosent, 6. Willing and able to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. With a past or present history of arterial thrombosism 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, compliations, subjective and objective symptms, vital signs and body weight, electrocardiograms or clinical laboratory results at screening or baseline, 5. QTcF > 450 ms (corrected for heart rate according to Fridericia's formula) category of the 12-lead electrocardiogram at screening or baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, tmax, AUC, t1/2 | — |
Outcome results
None listed