BPN14770 for Hepatic Impairment and Healthy Participants
BPN14770
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy 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
Orlando Clinical Research Center
Orlando, United StatesTexas Liver Institute
San Antonio, United States