OP-724-003 study

Drug-drug interaction study of Foscenvivint with CYP3A inhibitors in Healthy Male Volnteers (The phase I study).

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240671

Enrollment

Registered

2025-02-12

Start date

2025-03-24

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

Healthy volunteers

Interventions

Foscenvivint will be administered single intravenous infusion for 4 hours continuously. Itraconazole will be administered orally once a day repeatedly.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1: Healthy Japanese male subjects. 2: Age at the time of obtaining written informed consent is >=18 to <=45 years old. 3: Subjects who are capable of fully understanding the clinical trial and providing written informed consent.

Exclusion criteria

Exclusion criteria: 1: Subjects with any clinilcal abnormality assessed by the investigator or sub-investigator in laboratory tests, vital signs, or 12-lead ECG in eligibility test. 2: Subjects with a QTcF of >450 msec on a 12-lead ECG in the eligibility test. 3: Subjects who weighs <50.0 kg in the eligibility test.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics	—

Secondary

Measure	Time 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