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Liver impairment drug study completed: what happens to BPN14770?

NCT ID NCT07018492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how the drug BPN14770 is handled by the body in people with mild, moderate, or severe liver impairment compared to healthy people. A total of 32 adults took a single dose of the drug. Researchers measured drug levels in the blood and checked for side effects. The goal was to understand if liver problems change how the drug works, which is important for future safe use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BPN14770
What this could lead to
If successful, this study will help determine safe dosing of BPN14770 for people with liver problems, potentially guiding future treatment use.
What could go wrong
This is an early phase 1 study with only 32 people. It focuses on drug processing, not on treating any disease, so it may not lead to a new therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

32 people

The number who actually took part.

Started

Aug 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Division of Clinical Pharmacology, University of Miami

    Miami, Florida, 33136, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

  • Texas Liver Institute

    San Antonio, Texas, 78215, United States

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