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

Phase 1 Completed 82 enrolled Insmed Incorporated

RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start: 2019-01-09
Primary completion: 2019-08-01
Completion: 2019-08-01

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brensocatib	Small molecule	10 mg	Oral
Subject	Brensocatib	Small molecule	25 mg	Oral
Subject	Brensocatib	Small molecule	40 mg	Oral

Indications

No indication recorded.