OP-2024-002 Study

JRCT ID: jRCT2071220019

Registered date:29/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 06/07/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): In each cohort, OP-2024 will be administered orally in single doses of 1, 2, 4, and 6 capsules, respectively.

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Pharmacokinetics

Key inclusion & exclusion criteria

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

Include criteria

1) Healthy Japanese male.
2) Those with age >= 18 to <= 40 years.
3) Those with BMI >= 18.5 to < 25.0.
4) Those who have provided voluntary written consent to participate in the study.

Exclude criteria

1) Those with a history of allergies to investigational drug ingredients, drugs, or foods
2) Those who are undergoing treatment for, or have a history of, respiratory, circulatory, central nervous system, gastrointestinal, hepatic, renal, hematopoietic, or endocrine disorders that affect pharmacokinetics
3) Other protocol defined exclusion criteria could apply

Related Information

• Primary Sponsor: Taguchi Fumi