Phase I clinical study of Balovaptan in healthy Japanese male volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224648

Enrollment

Registered

2019-04-17

Start date

2019-05-23

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

investigational material(s) Generic name etc : Balovaptan INN of investigational material : Balovaptan Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administ

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese man between 20 and 45 years of age, inclusive, at time of consent. 2. Body mass index (BMI; weight in kg divided by height in meters squared) between 18.0 and 25.0 kg/m2, inclusive, at screening. 3. Agreement to use a form of contraception (hormonal contraceptive, intrauterine device, barrier method, etc., not including the rhythm method) from the day of the first dose of study drug until 90 days after the last dose, if the man has a partner of childbearing potential. 4. Written informed consent.

Exclusion criteria

Exclusion criteria: History or presence of clinically significant renal, hepatic, gastrointestinal, hematologic, immune, neurologic, endocrinologic, metabolic, or pulmonary disease, or current renal, hepatic, or cardiopulmonary impairment.

Design outcomes

Primary

Measure	Time frame
safety Observation/testing	—

Secondary

Measure	Time frame
pharmacokinetics testing	—

Countries

Japan

Outcome results

None listed

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