ONO-7684-02:Phase 1 study of the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-7684 in healthy Japanese adult male subjects

JRCT ID: jRCT2071220101

Registered date:31/01/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: TBD
• Date of first enrollment: 01/03/2023
• Target sample size: 48
• Study type: Interventional

Intervention(s)

1) Single dose Part
Subjects receive single oral dose of ONO-7684 or placebo.
2) Multiple dose Part
Subjects receive multiple oral doses of ONO-7684 or placebo.

Outcome(s)

• Primary Outcome: Safety, Tolerability, Pharmacokinetics
• Secondary Outcome: Pharmacodynamics

Key inclusion & exclusion criteria

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

Include criteria

1) Japanese healthy adult male subjects
2) Age at the time of informed consent: 18 to 45
3) BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m2

Exclude criteria

1) Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
2) Subjects with current or with a history of severe allergy to drugs or foods
3) Subjects with current or with a history of drug or alcohol abuse

Related Information

• Primary Sponsor: Masahiro Osawa