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A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment - Trial NCT05673603

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.

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NCT05673603
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05673603
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A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment
A Phase 1, Open-Label, Single Dose Parallel-Group Study of Brensocatib Following a Single Oral Administration in Subjects With or Without Renal Impairment

Study Focus

Renal Impairment

Brensocatib

Interventional

drug

Sponsor & Location

Insmed Incorporated

Orlando,Tampa,San Antonio, United States of America

Timeline & Enrollment

Phase 1

Jul 20, 2021

Feb 14, 2023

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 failure
Disorders resulting from impaired renal tubular function
Disorder resulting from impaired renal tubular function, unspecified
Other disorders resulting from impaired renal tubular function
Acute renal failure

Data Source

ClinicalTrials.gov

NCT05673603

Non-Device Trial