A Phase 1, Single-Dose, Multiple-Dose, Food Effect and Drug-Drug Interaction Study of BPN14770

JRCT ID: jRCT2031200182

Registered date:06/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Health Condition
• Date of first enrollment: 02/11/2020
• Target sample size: 112
• Study type: Interventional
• Intervention(s): Oral administration of BPN14770 or placebo

Outcome(s)

Primary Outcome

[Safety]
Adverse events, laboratory tests (hematology, blood chemistry, and urinalysis), vital signs (blood pressure, pulse rate, respiratory rate, and body temperature), 12-lead ECG, Columbia-Suicide Severity Rating Scale
[Pharmacokinetics]
BPN14770 : Maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC), terminal elimination half-life (t1/2,z), and terminal elimination rate constant (Lamda z), mean residence time (MRT), apparent total clearance (CL/F), and apparent volume of distribution in the terminal elimination phase (Vz/F)
Midazoram : Cmax,Tmax, AUC, t1/2,z , Lamda z, MRT
Donepezil Hydrochloride : Cmax, Tmax, AUC, CL/F

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1. Healthy Japanese or Caucasian adult participants aged >= 20 to <= 55 at the time of signing the informed consent form
2. Healthy Japanese elderly participants aged >= 65 to >= 75 at the time of signing the informed consent form

• Exclude criteria: History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metbolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data (depending on the judgement of investigator or subinvestigator)

Related Information

• Primary Sponsor: Nagata Tsutae