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

JRCT ID: jRCT2071210104

Registered date:26/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: narcolepsy
• Date of first enrollment: 12/01/2022
• Target sample size: 28
• Study type: Interventional
• Intervention(s): BF2.649 tablets or placebo tablets

Outcome(s)

• Primary Outcome: To evaluate the tolerability and safety of BF2.649 when administered as single and multiple oral doses in healthy Japanese adults

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male
• Include criteria: Healthy Japanese male volunteers aged 20 to 45 years

Exclude 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.

Related Information

• Primary Sponsor: Takuma Yonemura