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

NCT07018492 | Completed Phase 1 FDA Drug

• 1 other identifier: 2414A4112
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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

Keywords

Mild Hepatic Impairment (HI); Moderate HI; Severe HI

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770

  Predose up to 240 hours postdose

• Maximum Observed Plasma Concentration (Cmax) of BPN14770

  Predose up to 240 hours postdose

• Time Maximum Observed Plasma Concentration (Tmax) of BPN14770

  Predose up to 240 hours postdose

Secondary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Up to 15 days postdose

Study Arms (4)

Group 1: Mild HI

EXPERIMENTAL

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.

Drug: BPN14770

Group 2: Moderate HI

EXPERIMENTAL

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.

Drug: BPN14770

Group 3: Severe HI

EXPERIMENTAL

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.

Drug: BPN14770

Group 4: Normal Hepatic Function

EXPERIMENTAL

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

Drug: BPN14770

Interventions

BPN14770 DRUG

Administered as specified in the treatment arm.

Group 1: Mild HI; Group 2: Moderate HI; Group 3: Severe HI; Group 4: Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (3)

Division of Clinical Pharmacology, University of Miami

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

BPN14770

Study Officials

• Medical Director

  Shionogi Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 12, 2025
• Study Start: August 30, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)