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OP-2024-007 Study

Drug-drug interaction study of OP-2024 with Proton pump inhibitor (Rabeprazole Sodium) or Magnesium Oxide in Healthy Male Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031250158
Enrollment
20
Registered
2025-06-11
Start date
2025-06-18
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

OP-2024 will be administered as a single oral dose, alone and in combination with magnesium oxide or rabeprazole.

Sponsors

Hashimoto Hideaki
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Healthy Japanese male. 2) BMI at time of screening is >= 18.5 to < 25.0. 3) Written informed consent to participate in this trial can be obtained.

Exclusion criteria

Exclusion criteria: 1) History of allergies to any component of the investigational product, drug, or food. 2) Subjects with or at risk for angle-closure glaucoma. 3) Subjects with pheochromocytoma or paraganglioma, or other catecholamine-secreting tumors. 4) History of neuroleptic malignant syndrome or nontraumatic rhabdomyolysis. 5) History of diseases affecting the gastrointestinal tract, liver, kidneys, or heart that may influence the absorption, distribution, metabolism, or excretion of drugs. 6) History of major surgery involving the gastrointestinal tract, including gastrectomy, gastrostomy, or bowel resection (excluding appendectomy).

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics

Secondary

MeasureTime frame
Safety

Contacts

Public ContactHideaki Hashimoto

OHARA Pharmaceuitical 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