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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: Completed Phase 1 study, sponsored by Biogen.

NCT01503866 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
Biogen

334 total trials

What the finished NCT01503866 record still lists

NCT01503866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

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

NCT01503866 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01503866's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01503866, the US trial registry maintained by the National Library of Medicine. NCT01503866 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.