Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls (NCT07018492) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls
United States32 participantsStarted 2025-08-30
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 Ë—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…
What they're measuring
1
Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770
Timeframe: Predose up to 240 hours postdose
2
Maximum Observed Plasma Concentration (Cmax) of BPN14770
Timeframe: Predose up to 240 hours postdose
3
Time Maximum Observed Plasma Concentration (Tmax) of BPN14770