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A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male Subjects

NCT01503866 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-05-29

No results posted yet for this study

Summary

The purpose of this study is to determine the absorption and excretion kinetics of bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and feces in men following a single oral does or 20 mg of \[14C\]-bardoxolone methyl.

Conditions

  • Healthy

Interventions

DRUG

bardoxolone methyl

oral, single dose

Sponsors & Collaborators

Principal Investigators

  • Christine L Hale, MD · Covance Clinical Research Unit

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2011-12-31
Completion
2011-12-31

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 NCT01503866 on ClinicalTrials.gov