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The primary purpose of Part A of this study is to compare, in a single dose and multiple doses the safety, tolerability, and pharmacokinetics (PK) profile administered in Japanese and Caucasian participants and of Part B of the study is to assess the food effect of a single dose of INS1007 administered in Japanese and Caucasian participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Cohort 1 (Dose 1) | Experimental | Japanese and Caucasian participants will receive INS1007 at Dose 1 or matching placebo, orally, once on Day 1, and Day 4 through Day 30 in Part A under fasted conditions. |
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| Part A: Cohort 2 (Dose 2) | Experimental | Japanese and Caucasian participants will receive INS1007 at Dose 2 or matching placebo, orally, once on Day 1, and Day 4 through Day 30 in Part A under fasted conditions. |
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| Part A: Cohort 3 (Dose 3) | Experimental | Japanese and Caucasian participants will receive INS1007 at Dose 3 or matching placebo, orally, up to Day 30 in Part A under fasted conditions. Enrollment will commence in this cohort once the safety and tolerability data in Cohort 2 is deemed acceptable by the principal investigator (PI) and the Sponsor's medical monitor. |
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| Part B: Treatment Sequence 1 | Experimental | Japanese and Caucasian participants will receive INS1007 at the dose established in Part A after a high-fat and high-calorie breakfast on Day 1 followed by a dose established in Part A on Day 8 under fasted conditions in Part B of the study. |
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| Part B: Treatment Sequence 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INS1007 | Drug | Oral tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Number of Participants Who Experienced at Least One Adverse Event (AE) | Determination and comparison of the safety and tolerability of INS1007 following single and multiple dose administration in Japanese and Caucasian participants. | Up to Day 61 in Part A and up to Day 11 in Part B |
| Parts A and B: Area Under the Plasma Concentration-time Curve (AUC) of INS1007 | Comparison of the pharmacokinetics of single and multiple doses of INS1007 in Japanese and Caucasian participants. | Part A: Predose and at multiple time points postdose up to Day 33; Part B: Predose and at multiple time points postdose up to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacodynamic Activity Based on Concentration of Biomarkers in Blood | Pharmacodynamic activity based on concentration of biomarkers cathepsin G (Cat G), proteinase 3 (PR3), neutrophil elastase (NE), and absolute neutrophil in blood will be assessed. | Up to Day 61 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA001 | Glendale | California | 91206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35411669 | Result | Usansky H, Yoon E, Teper A, Zou J, Fernandez C. Safety, Tolerability, and Pharmacokinetic Evaluation of Single and Multiple Doses of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib in Healthy Japanese and White Adults. Clin Pharmacol Drug Dev. 2022 Jul;11(7):832-842. doi: 10.1002/cpdd.1094. Epub 2022 Apr 11. |
| Label | URL |
|---|---|
| Results are available in the link to the publication. | View source |
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| ID | Term |
|---|---|
| C000619932 | brensocatib |
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| Experimental |
Japanese and Caucasian participants will receive INS1007 at the dose established in Part A under fasted conditions on Day 1 followed by dose established in Part A on Day 8 after a high-fat and high-calorie breakfast in Part B of the study. |
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| Placebo | Drug | Oral tablets. |
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