OP-724-001 study

JRCT ID: jRCT2031230432

Registered date:05/11/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 10/11/2023
• Target sample size: 6
• Study type: Interventional
• Intervention(s): [14C]OP-724 will be administered intravenous for 4 hours continuously.

Outcome(s)

• Primary Outcome: Pharmacokinetics
• Secondary Outcome: Satety

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 subinvestigator in laboratory tests, vital signs, or 12-lead ECG in eligibility testing.
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: Yuushi Haruyama