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The primary purpose of the study is to compare the PK of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Brensocatib | Experimental | Healthy participants with normal hepatic 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 hepatic impairment. |
|
| Cohort 2: Brensocatib | Experimental | Participants with mild hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
|
| Cohort 3: Brensocatib | Experimental | Participants with moderate hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
|
| Cohort 4: Brensocatib | Experimental | Participants with severe hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brensocatib | Drug | Oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Time Curve (AUC) | Comparison of the pharmacokinetics of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function. | Pre-dose and at multiple timepoints post-dose on Days 1 to 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Fraction Unbound (Fu) | Assessment of the plasma protein binding of brensocatib in participants with varying degrees of hepatic function relative to matched healthy control participants with normal hepatic function. | Pre-dose and at multiple timepoints post-dose on Days 1 to 9 |
| Number of Participants who Experienced at Least one Adverse Event (AE) |
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Inclusion Criteria:
- Has body mass index (BMI) between 18.0 and 35.0 kilogram per square meter (kg/m^2)
Inclusion Criteria for Participants With Hepatic Impairment:
Inclusion Criteria for Healthy Matched Control Participants With Normal Hepatic Function:
Exclusion Criteria:
Exclusion Criteria for Participants With Hepatic Impairment:
Exclusion Criteria for Healthy Matched Control Participants with Normal Hepatic Function
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA002 | Rialto | California | 92377 | United States | ||
| USA003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41586857 | Derived | Usansky H, Au Yeung S, Li S, Marbury T, Lawitz E, Kayali Z, Stein DS. Pharmacokinetics and Safety of a Single Dose of Brensocatib in Participants with Hepatic Impairment and Matched Participants with Normal Hepatic Functions. Clin Pharmacokinet. 2026 Mar;65(3):441-452. doi: 10.1007/s40262-025-01614-0. Epub 2026 Jan 26. |
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|
Determination of the safety and tolerability of a single dose of brensocatib in participants with hepatic impairment. |
| From first dose of study drug up to follow up visit (5-7 days after discharge) or early termination (up to Day 17) |
| Orlando |
| Florida |
| 32809 |
| United States |
| USA001 | San Antonio | Texas | 78215 | United States |
| ID | Term |
|---|---|
| C000619932 | brensocatib |
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