Skip to main content
OpenTrials
Completed

NCT Number: NCT07018492

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Division of Clinical Pharmacology, University of Miami, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BPN14770

Drug

Administered as specified in the treatment arm.

Primary outcomes

  1. Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770

    Time frame: Predose up to 240 hours postdose

  2. Maximum Observed Plasma Concentration (Cmax) of BPN14770

    Time frame: Predose up to 240 hours postdose

  3. Time Maximum Observed Plasma Concentration (Tmax) of BPN14770

    Time frame: Predose up to 240 hours postdose

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 15 days postdose

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.