Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls

NCT ID: NCT07018492

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2025-12-31

Brief Summary

The primary purpose of this study is to assess the pharmacokinetics (PK) of BPN14770 after a single oral administration of BPN14770 in participants with mild, moderate, and severe liver impairment compared with control participants with normal hepatic function.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: Mild HI

Participants with mild hepatic impairment who have a Child Pugh classification system score of Class A will receive a single oral dose of BPN14770 capsule on Day 1.

Group Type: EXPERIMENTAL

BPN14770

Intervention Type: DRUG

Administered as specified in the treatment arm.

Group 2: Moderate HI

Participants with moderate hepatic impairment who have a Child Pugh classification system score of Class B will receive a single oral dose of BPN14770 capsule on Day 1.

Group Type: EXPERIMENTAL

BPN14770

Intervention Type: DRUG

Administered as specified in the treatment arm.

Group 3: Severe HI

Participants with severe hepatic impairment who have a Child Pugh classification system score of Class C will receive a single oral dose of BPN14770 capsule on Day 1.

Group Type: EXPERIMENTAL

BPN14770

Intervention Type: DRUG

Administered as specified in the treatment arm.

Group 4: Normal Hepatic Function

Participants with normal hepatic function will receive a single oral dose of BPN14770 capsule on Day 1.

Group Type: EXPERIMENTAL

BPN14770

Intervention Type: DRUG

Administered as specified in the treatment arm.

Interventions

BPN14770

Administered as specified in the treatment arm.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Considered to be healthy (for healthy participants) or medically stable (for participants with hepatic impairment), as determined by medical evaluation.
• Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range ≥ 18.5 to < 40.0 kilograms per square meter (kg/m^2).
• A diagnosis of clinically stable hepatic disease for at least 1 month prior to the screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique.
• Mild, moderate, and severe hepatic impairment based on the Child-Pugh classification score at the screening visit and Day ˗1 to determine eligibility:

• Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6)
• Moderate (Class B) hepatic impairment (Child-Pugh classification score 7 to 9)
• Severe (Class C) hepatic impairment (Child-Pugh classification score 10 to 15)
• Healthy Participants matched to each participant with moderate hepatic impairment with respect to sex, age (± 10 years), and BMI (± 10%)

Exclusion Criteria

• History or presence of/significant history of or current cardiovascular, respiratory, hepatic, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data, in the judgment of the investigator.
• Blood loss or blood donation that exceeds 500 milliliters (mL) within 56 days prior to or at the screening visit or donation of any amount of blood from the screening visit until admission to the clinical research unit (CRU).
• Healthy participants:

• Clinical laboratory values outside the reference range during the screening period or on Day ˗1 and considered clinically significant by the investigator
• Alanine aminotransferase or aspartate aminotransferase > 1.5 * the upper limit of normal (ULN) or bilirubin ≥ 1.0 * the ULN.
• Participants with hepatic impairment:

• Participant with clinically significant laboratory values in the opinion of the investigator or outside the acceptable ranges or limits during the screening period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Shionogi Inc.

Locations

Division of Clinical Pharmacology, University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status: RECRUITING

Texas Liver Institute

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

Role: CONTACT

Shionogiclintrials-admin@shionogi.co.jp

1-800-849-9707

Other Identifiers

2414A4112

Identifier Type: -

Identifier Source: org_study_id