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OP-2024-005 Study

Food effect study of OP-2024 in healthy male adults

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071230034
Enrollment
24
Registered
2023-06-27
Start date
2023-07-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

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.

Sponsors

Taguchi Fumi
Lead Sponsor

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) 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

MeasureTime frame
Pharmacokinetics

Secondary

MeasureTime frame
Safety

Contacts

Public ContactDepartment of Clinical Development

OHARA Pharmaceutical Co.,Ltd.

chiken@ohara-ch.co.jp+81-3-6740-7701

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026