A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants

NCT ID: NCT05927597

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2019-08-01

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A: Cohort 1 (Dose 1)

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.

Group Type: EXPERIMENTAL

INS1007

Intervention Type: DRUG

Oral tablets.

Placebo

Intervention Type: DRUG

Oral tablets.

Part A: Cohort 2 (Dose 2)

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.

Group Type: EXPERIMENTAL

INS1007

Intervention Type: DRUG

Oral tablets.

Placebo

Intervention Type: DRUG

Oral tablets.

Part A: Cohort 3 (Dose 3)

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.

Group Type: EXPERIMENTAL

INS1007

Intervention Type: DRUG

Oral tablets.

Placebo

Intervention Type: DRUG

Oral tablets.

Part B: Treatment Sequence 1

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.

Group Type: EXPERIMENTAL

INS1007

Intervention Type: DRUG

Oral tablets.

Part B: Treatment Sequence 2

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.

Group Type: EXPERIMENTAL

INS1007

Intervention Type: DRUG

Oral tablets.

Interventions

INS1007

Oral tablets.

Intervention Type: DRUG

Placebo

Oral tablets.

Intervention Type: DRUG

Other Intervention Names

AZD7986; Brensocatib

Eligibility Criteria

Inclusion Criteria

• For Japanese participants: Participant is of Japanese descent as evidenced by verbal confirmation of familial heritage (a participant must have all four grandparents born in Japan). Participants must have lived less than 10 years outside of Japan.
• For Caucasian participants: Participants must be of Caucasian descent, as evidenced by verbal confirmation that all four grandparents are Caucasian.
• Healthy, based on pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations) by the PI or designee.

Exclusion Criteria

• Have clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the PI or designee.
• Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to Screening. Examples may include, but are not limited to, infections requiring intravenous (IV) antibiotics, hospitalization, or prolonged (>14 day) anti-infective treatment.
• Have a history of multiple or severe allergies, or an anaphylactic reaction, to prescription or non-prescription drugs or food.
• Have a positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antigen or antibody at the Screening Visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USA001

Glendale, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 35411669 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/35411669/

Results are available in the link to the publication.

Other Identifiers

INS1007-101

Identifier Type: -

Identifier Source: org_study_id