Recruiting

BPN14770 for Hepatic Impairment and Healthy Participants

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

BPN14770

Drug
Who is being recruted

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorShionogi
Study ContactShionogi Clinical Trials Administrator Clinical Support Help Line
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 30, 2025

Actual date on which the first participant was enrolled.

This study aims to understand how the drug BPN14770 behaves in the bodies of people with different levels of liver impairment. It includes participants with mild, moderate, and severe liver issues, as well as healthy individuals for comparison. This research is essential because it could reveal how liver health affects the processing of BPN14770, which can help adjust dosages and improve treatment safety and effectiveness for those with liver problems. Participants will take a single dose of BPN14770 orally. Researchers will then measure the drug levels in the blood over time to see how the body absorbs, distributes, and eliminates it. This study also monitors any side effects or adverse reactions to ensure the drug is safe for people with varying liver function. By comparing results across different groups, the study can provide valuable insights into adjusting treatments for people with liver impairments.

Official TitleA 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 
NCT07018492
Principal SponsorShionogi
Study ContactShionogi Clinical Trials Administrator Clinical Support Help Line
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Key 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%) Key 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Group IV

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

Division of Clinical Pharmacology, University of Miami

Miami, United StatesSee the location
Recruiting

Orlando Clinical Research Center

Orlando, United States
Recruiting

Texas Liver Institute

San Antonio, United States
Recruiting
3 Study Centers