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The primary purpose of the study is to determine the pharmacokinetics (PK) following a single oral dose administration of brensocatib, safety, and tolerability of brensocatib when administered to participants with impaired renal function and in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Mild Impairment): Brensocatib | Experimental | Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
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| Cohort 2 (Moderate Impairment): Brensocatib | Experimental | Participants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
|
| Cohort 3 (Severe Impairment): Brensocatib | Experimental | Participants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
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| Cohort 4 (Normal): Brensocatib | Experimental | Healthy participants with normal renal function will receive single oral dose of brensocatib on Day 1 under fasted conditions. Healthy participants will be matched within the protocol criteria to one or more participants with renal impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brensocatib | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib | Pharmacokinetics of brensocatib following a single dose will be assessed in participants with renal impairment and in healthy participants. | Pre-dose and at multiple timepoints post-dose on Days 1 to 14 |
| Maximum Observed Plasma Concentration (Cmax) of Brensocatib | Pre-dose and at multiple timepoints post-dose on Days 1 to 14 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib | Pre-dose and at multiple timepoints post-dose on Days 1 to 14 | |
| Number of Participants who Experienced at Least one Adverse Event (AE) | Determination of the safety and tolerability of a single dose of brensocatib in participants with impaired renal function and in healthy participants. | Up to Day 14 |
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Inclusion Criteria:
Inclusion Criteria (for Participants With Renal Impairment):
Inclusion Criteria for Healthy Participants:
Exclusion Criteria:
Exclusion Criteria (for Participants With Renal Impairment):
Exclusion Criteria (for Healthy Participants):
Note: Other inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA002 | Orlando | Florida | 32809 | United States | ||
| USA003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39574348 | Derived | Yeung SA, Stein DS, Marbury TC, Usansky H. The pharmacokinetics of brensocatib in participants with renal impairment following a single oral administration. Br J Clin Pharmacol. 2025 Apr;91(4):1191-1197. doi: 10.1111/bcp.16344. Epub 2024 Nov 22. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000619932 | brensocatib |
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|
| Tampa |
| Florida |
| 33603 |
| United States |
| USA001 | San Antonio | Texas | 78215 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |