Clinical trial NCT07018492: Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Mild Hepatic Impairment (HI)
Moderate HI
Severe HI
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770
timeFrame: Predose up to 240 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax) of BPN14770
timeFrame: Predose up to 240 hours postdose
measure: Time Maximum Observed Plasma Concentration (Tmax) of BPN14770
timeFrame: Predose up to 240 hours postdose
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 15 days postdose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Division of Clinical Pharmacology, University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: San Antonio
country: United States
facility: American Research Corporation dba Texas Liver Institute
state: Texas
Study officials:
affiliation: Shionogi Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: