Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Participants With Severe Renal Impairment | Experimental | Participants with severe renal impairment will receive a single dose of BPN14770 administered orally in the fasted state on Day 1. |
|
| Group 2: Participants With Normal Renal Function | Experimental | Participants with normal renal function will receive a single dose of BPN14770 administered orally in the fasted state on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPN14770 | Drug | BPN14770 will be administered per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of BPN14770 | 0 (predose) up to 240 hours postdose on Day 1 to Day 11 | |
| Time to Reach Cmax (Tmax) of BPN14770 | 0 (predose) up to 240 hours postdose on Day 1 to Day 11 | |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of BPN14770 | 0 (predose) up to 240 hours postdose on Day 1 to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Day 15 |
Not provided
Inclusion Criteria:
All Participants:
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:
Exclusion Criteria:
All Participants:
Participants With Renal Impairment:
NOTE: Other protocol-specified inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Clinical Pharmacology, University of Miami | Miami | Florida | 33136 | United States | ||
| Orlando Clinical Research Center |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723101 | BPN14770 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Orlando |
| Florida |
| 32809 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |