A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 (Mild Impairment): Brensocatib Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
Drug: Brensocatib
Oral tablet
Other Names:
|
| Experimental: Cohort 2 (Moderate Impairment): Brensocatib Participants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
Drug: Brensocatib
Oral tablet
Other Names:
|
| Experimental: Cohort 3 (Severe Impairment): Brensocatib Participants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions. |
Drug: Brensocatib
Oral tablet
Other Names:
|
| Experimental: Cohort 4 (Normal): Brensocatib 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. |
Drug: Brensocatib
Oral tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib [Pre-dose and at multiple timepoints post-dose on Days 1 to 14]
Pharmacokinetics of brensocatib following a single dose will be assessed in participants with renal impairment and in healthy participants.
- 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) [Up to Day 14]
Determination of the safety and tolerability of a single dose of brensocatib in participants with impaired renal function and in healthy participants.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Has a body mass index (BMI) 18 to 35 kilograms per square meter (kg/m^2), inclusive, and a body weight of ≥50 kg at Screening.
Inclusion Criteria (for Participants With Renal Impairment):
-
Mild, moderate, or severe renal impairment as determined by estimated glomerular filtration rate (eGFR) and calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
-
Renal insufficiency or other related concomitant medical conditions (e.g., hypertension, anemia) has remained stable for at least 3 months before study drug dosing.
Inclusion Criteria for Healthy Participants:
-
Normal renal function as determined by eGFR and calculated using the CKD-EDI formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.
-
In good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings.
Exclusion Criteria:
-
Positive test result for human immunodeficiency virus types 1 or 2 antibodies, hepatitis C virus antibodies, or hepatitis B surface antigen or hepatitis B core antibodies.
-
History of relevant drug and/or food allergies (i.e., allergy to brensocatib or any excipients, or any significant food allergy).
-
The participant has received study drug in another investigational study within 30 days of Screening.
Exclusion Criteria (for Participants With Renal Impairment):
-
Has nephrotic syndrome, defined as urine dipstick 4+ for protein and plasma albumin <3.0 grams per deciliter (g/dL), and then confirmed if proteinuria >5 g/day.
-
Has an extrarenal cause of renal impairment (e.g., rapidly growing, space occupying lesions, adrenal enlargement).
-
Has a functioning renal transplant (participant may be included in the study if he or she had a failed renal transplant and is not taking immunosuppressants).
-
Has a hemoglobin value less than 8.5 g/dL.
-
Has Type 1 or Type 2 diabetes mellitus.
Exclusion Criteria (for Healthy Participants):
- Has used any prescription (excluding hormonal birth control, hormone replacement therapy, nonsteroidal anti-inflammatory drugs, or acetaminophen) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before study drug dosing and throughout the study.
Note: Other inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | USA002 | Orlando | Florida | United States | 32809 |
| 2 | USA001 | San Antonio | Texas | United States | 78215 |
Sponsors and Collaborators
- Insmed Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INS1007-102