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A Randomized, Double-blind, Placebo-controlled, Single-center, Single and Multiple Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BF2.649 (pitolisant hydrochloride) in Healthy Japanese Adult Subjects

A Randomized, Double-blind, Placebo-controlled, Single-center, Single and Multiple Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BF2.649 (pitolisant hydrochloride) in Healthy Japanese Adult Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071210104
Enrollment
28
Registered
2021-12-26
Start date
2022-01-12
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

narcolepsy

Interventions

BF2.649 tablets or placebo tablets

Sponsors

Takuma Yonemura
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Healthy Japanese male volunteers aged 20 to 45 years

Exclusion criteria

Exclusion criteria: 1. Individuals with a history of drug allergy, food allergy, allergic rash, asthma, intolerance or hypersensitivity to some drugs, or photosensitivity 2. Having alcohol or drug dependence etc.

Design outcomes

Primary

MeasureTime frame
To evaluate the tolerability and safety of BF2.649 when administered as single and multiple oral doses in healthy Japanese adults—

Contacts

Public ContactOno Chihiro

CMIC Co., Ltd.

ClinicalTrialInformation@cmic.co.jp+81-80-8700-5366

Outcome results

None listed

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