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NCT01461161 · ClinicalTrials.gov registry record · Phase 1

A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl

A Phase 1 study, sponsored by Biogen.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT01461161 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 32 participants.

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The verdict

NCT01461161, a Phase 1 study, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects.

Interventions

  • DRUG bardoxolone methyl

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2011-10-31
Est. Completion 2011-12-31
Phase Phase 1

Sponsor

Biogen

334 total trials

What the Registry Record Tells You About NCT01461161

The ClinicalTrials.gov registry entry for NCT01461161 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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.

NCT01461161 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01461161 about?

NCT01461161 is a clinical study titled "A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl". This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl administered to normal healthy adult subjects.

What is the current status of trial NCT01461161?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-10-31. Estimated completion is 2011-12-31.

What interventions are being tested in trial NCT01461161?

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

Who is sponsoring clinical trial NCT01461161?

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.