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Mass Balance Study of KBP-5074 in Healthy Male Subjects

NCT04634812 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-12-16

No results posted yet for this study

Summary

This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

KBP-5074

a single oral dose of \[14C\]-KBP-5074

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • KBP Biosciences

    lead INDUSTRY

Principal Investigators

  • James McCabe · KBP Biosciences

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2020-12-23
Completion
2020-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04634812 on ClinicalTrials.gov