Recruiting

BPN14770 for Hepatic Impairment and Healthy Participants

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What is being tested

BPN14770

Drug
Who is being recruted

Hepatic Impairment

From 18 to 80 Years
+17 Eligibility Criteria

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: September 5, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 30, 2025Actual 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 
Principal SponsorShionogi
Study ContactShionogi Clinical Trials Administrator Clinical Support Help Line
Last updated: September 5, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hepatic Impairment
Criteria
9 inclusion criteria required to participate
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

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8 exclusion criteria prevent from participating
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

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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 MiamiMiami, United StatesSee the location
Recruiting
Orlando Clinical Research CenterOrlando, United States
Recruiting
Texas Liver InstituteSan Antonio, United States
Recruiting
3 Study Centers