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

NCT05927597 | Completed Phase 1 FDA Drug

• 1 other identifier: INS1007-101
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Part A: Pharmacodynamic Activity Based on Concentration of Biomarkers in Blood

  Up to Day 61

Study Arms (5)

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.

Drug: INS1007; Drug: Placebo

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.

Drug: INS1007; Drug: Placebo

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.

Drug: INS1007; Drug: Placebo

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.

Drug: INS1007

Part B: Treatment Sequence 2

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.

Drug: INS1007

Interventions

INS1007 DRUG

Oral tablets.

Also known as: AZD7986, Brensocatib

Part A: Cohort 1 (Dose 1); Part A: Cohort 2 (Dose 2); Part A: Cohort 3 (Dose 3); Part B: Treatment Sequence 1; Part B: Treatment Sequence 2

Placebo DRUG

Oral tablets.

Part A: Cohort 1 (Dose 1); Part A: Cohort 2 (Dose 2); Part A: Cohort 3 (Dose 3)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (1)

USA001

Glendale, California, 91206, United States

Location

Related Publications (1)

• 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.

  PMID: 35411669 RESULT

Related Links

• Results are available in the link to the publication.

MeSH Terms

Interventions

brensocatib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: January 9, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)