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A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Participants

NCT05652257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-03-23

No results posted yet for this study

Summary

The primary purpose of the study is to determine the mass balance of total radioactivity and the routes of elimination by quantifying the urinary and fecal excretion of radioactivity following a single oral administration of \[14C\]-brensocatib, to characterize the pharmacokinetics (PK) of brensocatib in plasma and urine, PK of total radioactivity in plasma, whole blood, urine and to determine the blood-to-plasma ratios of total radioactivity.

Conditions

  • Healthy Volunteers

Interventions

DRUG

[14C]-brensocatib

Oral solution.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-13
Primary Completion
2021-09-14
Completion
2021-09-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652257 on ClinicalTrials.gov