Phase 1 Clinical Study of JTV-261 -Single and Multiple Dose Study-

JRCT ID: jRCT2071240028

Registered date:05/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 05/08/2024
• Target sample size: 88
• Study type: Interventional

Intervention(s)

Part 1: Administration of a single dose of JTV-261 or placebo in the fasted or fed state.
Part 2: Administration of multiple doses of JTV-261 or placebo for 14 days in the fasted state.

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

1. Healthy Japanese male aged from 20 to 45 years
2. A subject with a body mass index (BMI) of 18.5 to less than 25.0

Exclude criteria

1. A subject who has serious medical history of or complications under treatment for the cerebral, liver, kidneys, heart, lungs, gastrointestinal system, hematological, endocrine system, metabolic system, or psychiatric disorders.
2. A subjcet who has a history of gastrointestinal surgery that could interfere with the absorption of the study drug.
3. A subject who has participated in this study and received the study drug administration.
4. A subject who, in the opinion of the Investigator, has impediments to participation in the study.

Related Information

• Primary Sponsor: Mitsui Hironori