Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls (NCT07012005) | Clinical Trial Compass
CompletedPhase 1
Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls
United States14 participantsStarted 2025-08-25
Plain-language summary
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those with normal renal function.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
All Participants:
* Considered to be healthy (for healthy participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including medical/surgical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram (ECG) during the screening period and upon admission to the clinical research unit (CRU).
* Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range 18.5 to \<40.0 kg/square meter (m\^2) (inclusive)
Participants With Renal Impairment:
* Participants that are not undergoing hemodialysis and have severe renal impairment based upon their 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine formula creatinine clearance estimate (CLcr) estimated glomerular filtration rate (eGFR) estimate and the participant's body surface area (BSA) calculated at the screening visit
a. Severe renal impairment: eGFR \<30 milliliters (mL)/minute (min)
* A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the follow-up/early termination visit.
Healthy Participants:
* Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by 2021 CKD-EPI creatinine formula and the participant'…
What they're measuring
1
Maximum Plasma Concentration (Cmax) of BPN14770
Timeframe: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
2
Time to Reach Cmax (Tmax) of BPN14770
Timeframe: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
3
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of BPN14770
Timeframe: 0 (predose) up to 240 hours postdose on Day 1 to Day 11