OP-2024-005 Study

JRCT ID: jRCT2071230034

Registered date:27/06/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 14/07/2023
• Target sample size: 24
• Study type: Interventional
• Intervention(s): A single oral dose of 3 capsules of OP-2024 will be administered under any one meal condition (fasting, after meal or before meal) on Day 1 of each 3-day period in Periods 1, 2, and 3.

Outcome(s)

• Primary Outcome: Pharmacokinetics
• Secondary Outcome: 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) 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