Recurrent or exacerbated diffuse midline glioma
Conditions
Interventions
A single oral dose of 1 capsule of OP-10(JP) or OP-10(US) will be adminisrated with approximately 150 mL of water under fasting for at least 10 hours on Day 1 of each 6-day period in Period 1 or Perio
Sponsors
Taguchi Fumi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese male. 2) Age at the time of obtaining written informed consent is >= 18 to = 18.5 to < 25.0. 4) Agreement to use contraception and refrain from sperm donation between Day 1 of Period 1 and 180 days after the last dose of study intervention. 5) Written informed consent to participate in this trial can be obtained.
Exclusion criteria
Exclusion criteria: 1) History of allergy to investigational drug ingredients, drugs, or foods. 2) History of or undergoing treatment for any diseases of respiratory, circulatory, central nervous system, gastrointestinal, hepatic, renal, hematological, or endocrine disorders that affect pharmacokinetics. 3) Other protocol defined exclusion criteria could be applied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Cmax, AUC(0-t)) of OP-10 | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Pharmacokinetics (2)Safety | — |
Contacts
Public ContactDepartment of Clinical Development
OHARA Pharmaceutical Co.,Ltd.
Outcome results
None listed