A Phase 1, Single-Dose, Multiple-Dose, Food Effect and Drug-Drug Interaction Study of BPN14770
Phase 1
- Conditions
- Health Condition
- Registration Number
- JPRN-jRCT2031200182
- Lead Sponsor
- agata Tsutae
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 112
Inclusion 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
Exclusion 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [Safety] <br>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<br>[Pharmacokinetics]<br>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)<br>Midazoram : Cmax,Tmax, AUC, t1/2,z , Lamda z, MRT<br>Donepezil Hydrochloride : Cmax, Tmax, AUC, CL/F
- Secondary Outcome Measures
Name Time Method