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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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'…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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