Nonalcoholic Steatohepatitis
Conditions
Interventions
Single or multiple oral doses of EA3571 or placebo
Sponsors
Takeuchi Yutaka
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. A Japanese or Caucasian healthy adult aged between 20 and 44 inclusive at the time of written informed consent 2. A BMI meeting the following criterion at screening: Japanese subjects, >= 18.5 and = 18.5 and < 30.0 kg/m2 3. Consenting in writing to participate in this clinical study on his/her own free will and able to comply with the requirements in the clinical study
Exclusion criteria
Exclusion criteria: 1. Surgical history at screening that affects the PK of the investigational product 2. History or complication at screening or any physical finding, vital sign, ECG finding, or laboratory value at screening or baseline that raises suspicion of a clinically abnormal symptom or organ dysfunction that requires treatment 3. History of allergy to gelatin, other foods, or any drugs at screening 4. Use of prescription drugs or over-the-counter drugs within 4 weeks before the investigational product administration 5. Ongoing participation in another clinical study, or use of an investigational product or device while participating in another clinical study within 16 weeks before giving consent 6. Anyone deemed ineligible to participate in this clinical study by the investigator or sub investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: AEs, Laboratory tests, Vital signs, Body weight, 12-lead ECGs, Physical findings Pharmacokinetics: Plasma EA3571 concentrations, Urinary EA3571 excretions | — |
Contacts
Public ContactYutaka Takeuchi
EA Pharma Co., Ltd
Outcome results
None listed