NCT05673603

A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment

Name: Clinical Trial NCT05673603
Creator: Insmed Incorporated
Keywords: Renal Impairment, Brensocatib, Phase 1, drug, clinical trial, United States of America

A Phase 1, Open-Label, Single Dose Parallel-Group Study of Brensocatib Following a Single Oral Administration in Subjects With or Without Renal Impairment

Insmed Incorporated·Phase 1·ClinicalTrials.gov·drugCompleted

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Renal Impairment
Drug/Device/Intervention: Brensocatib
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Insmed Incorporated
Location: Orlando,Tampa,San Antonio, United States of America

Timeline & enrollment

Phase: Phase 1
Start date: Jul 20, 2021
End date: Feb 14, 2023
Enrollment: 28 participants

Primary outcome

Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib,Maximum Observed Plasma Concentration (Cmax) of Brensocatib,Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib,Number of Participants who Experienced at Least one Adverse Event (AE)

Summary

The primary purpose of the study is to determine the pharmacokinetics (PK) following a single oral dose administration of brensocatib, safety, and tolerability of brensocatib when administered to participants with impaired renal function and in healthy participants.

ICD-10 classifications

Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05673603
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05673603 through Pure Global AI's free database. This Phase 1 trial is sponsored by Insmed Incorporated and is currently Completed. The study focuses on Renal Impairment. Target enrollment is 28 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.