Healthy Volunteer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Japanese healthy men and women or Caucasian healthy men - Individuals >=18 to <45 years of age at the time of informed consent - Individuals who fully understand the details of the study and who are capable of providing written informed consent
Exclusion criteria
Exclusion criteria: - Subjects with clinical abnormalities in laboratory tests, vital signs, or fixed 12-lead electrocardiogram (ECG) - Subjects under 50.0 kg in men, less than 45.0 kg in women (in some parts: less than 50.0 kg) - Subjects with a BM of 1 (Japanese men: less than 18.5 kg/m2 or greater than 25.0 kg/m2; Japanese women: less than 17.5 kg/m2 or greater than 25.0 kg/m2; Caucasian: less than 18.5 kg/m2 or greater than 30.0 kg/m2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoints: Pharmacokinetic parameters Safety endpoints: Adverse events, vital signs, clinical tests, ECG test | — |
Contacts
ASAHI KASEI THERAPEUTICS CORPORATION