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NCT01503866 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Biogen.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT01503866 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 6 participants.

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The verdict

NCT01503866, a Phase 1 study, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

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.

Interventions

  • DRUG bardoxolone methyl

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2011-12-01
Est. Completion 2011-12-31
Phase Phase 1

Sponsor

Biogen

334 total trials

What the Registry Record Tells You About NCT01503866

The ClinicalTrials.gov registry entry for NCT01503866 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which bardoxolone methyl is the first listed.

NCT01503866 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01503866 about?

NCT01503866 is a clinical study titled "A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male Subjects". 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.

What is the current status of trial NCT01503866?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-12-01. Estimated completion is 2011-12-31.

What interventions are being tested in trial NCT01503866?

The interventions under investigation include: bardoxolone methyl (DRUG).

Who is sponsoring clinical trial NCT01503866?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.