OP-724-003 study

JRCT ID: jRCT2031240671

Registered date:12/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 24/03/2025
• Target sample size: 6
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Pharmacokinetics
• Secondary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Haruyama Yuushi