A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses and the Open-Label Food Effect of a Single Dose of INS1007 in Healthy Japanese and Caucasian Subjects
Overview
- Phase
- Phase 1
- Intervention
- INS1007
- Conditions
- Healthy Volunteers
- Sponsor
- Insmed Incorporated
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Parts A and B: Number of Participants Who Experienced at Least One Adverse Event (AE)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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.
Intervention: INS1007
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.
Intervention: Placebo
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.
Intervention: INS1007
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.
Intervention: Placebo
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.
Intervention: INS1007
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.
Intervention: Placebo
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.
Intervention: INS1007
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.
Intervention: INS1007
Outcomes
Primary Outcomes
Parts A and B: Number of Participants Who Experienced at Least One Adverse Event (AE)
Time Frame: Up to Day 61 in Part A and up to Day 11 in Part B
Determination and comparison of the safety and tolerability of INS1007 following single and multiple dose administration in Japanese and Caucasian participants.
Parts A and B: Area Under the Plasma Concentration-time Curve (AUC) of INS1007
Time Frame: 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
Comparison of the pharmacokinetics of single and multiple doses of INS1007 in Japanese and Caucasian participants.
Secondary Outcomes
- Part A: Pharmacodynamic Activity Based on Concentration of Biomarkers in Blood(Up to Day 61)