RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of BPN14770 in Participants With Mild, Moderate, and Severe Hepatic Impairment and Healthy Control Participants

Quick Facts

Study Start:2025-08-30

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07018492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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%)	* 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.

Inclusion Criteria

Exclusion 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%)

* 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.

Contacts and Locations

Study Contact

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

1-800-849-9707

Shionogiclintrials-admin@shionogi.co.jp

Principal Investigator

Medical Director

STUDY_DIRECTOR

Shionogi Inc.

Study Locations (Sites)

Division of Clinical Pharmacology, University of Miami

Miami, Florida, 33136

United States

Orlando Clinical Research Center

Orlando, Florida, 32809

United States

American Research Corporation dba Texas Liver Institute

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: Shionogi

Medical Director, STUDY_DIRECTOR, Shionogi Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-30

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-08-30

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Mild Hepatic Impairment (HI)
Moderate HI
Severe HI

Additional Relevant MeSH Terms

Hepatic Impairment