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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071240028

Enrollment

Registered

2024-07-05

Start date

2024-08-05

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 volunteer

Interventions

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.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Safety, Pharmacokinetics	—

Contacts

Public Contactinformation clinical

Shionogi & Co.,Ltd.

clinicaltrials-info@shionogi.co.jp+81-3-6635-3505

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026