NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031200182

Registered date:06/11/2020

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedHealth Condition
Date of first enrollment02/11/2020
Target sample size112
Countries of recruitmentJapan
Study typeInterventional
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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria1. 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 criteriaHistory 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

Contact

Public contact
Name Corporate Communications Department
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; Co., Ltd.
Scientific contact
Name Tsutae Nagata
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; Co., Ltd.