OP-10-002 Study

JRCT ID: jRCT2071230132

Registered date:28/03/2024

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Recurrent or exacerbated diffuse midline glioma
• Date of first enrollment: 20/05/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): 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 Period 2.

Outcome(s)

• Primary Outcome: Pharmacokinetics (Cmax, AUC(0-t)) of OP-10
• Secondary Outcome: (1)Pharmacokinetics (2)Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

1) Healthy Japanese male.
2) Age at the time of obtaining written informed consent is >= 18 to <= 40 years old.
3) BMI at time of screening is >= 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.

Exclude 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.

Related Information

• Primary Sponsor: Taguchi Fumi