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

A Phase 1, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of BPN14770, A Randomized, Open-label, 2-Period Crossover Study to Assess the Effect of Food on the Pharmacokinetics of BPN14770, and An Open-label, Add-on Study to Assess the Drug-Drug Interaction Between BPN14770 and Midazolam and Between BPN14770 and Donepezil Hydrochloride, in Healthy Young and/or Elderly Participants

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200182

Enrollment

112

Registered

2020-11-06

Start date

2020-11-02

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

Health Condition

Interventions

Oral administration of BPN14770 or placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese or Caucasian adult participants aged >= 20 to = 65 to >= 75 at the time of signing the informed consent form

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
[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	—

Measure

Time frame

[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

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Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

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