NCT05927597

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	INS1007	Oral tablets.
DRUG	Placebo	Oral tablets.

Timeline

• Start date: 2019-01-09
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study