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NCT03264079 · ClinicalTrials.gov registry record · Phase 1

Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults

A Phase 1 study of Healthy Volunteers, sponsored by Biogen.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target
1
Study location

NCT03264079 is a Phase 1 study of Healthy Volunteers that has completed, run by Biogen. The registered enrollment target is 16 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03264079, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target
1
Study location

Study Summary

This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects. This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy volunteers. Subjects will complete a screening visit within 28 days of Study Day 1. Subjects must qualify for the study based on inclusion/exclusion criteria. For Period 1, all qualified subjects shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2, following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration). Bardoxolone methyl doses will be administered under fasted conditions. Itraconazole will be administered under fed conditions on Study Days 15-17, and Study Days 19-27. On study Day 18, itraconazole will be administered under fasted conditions. Subjects will be confined beginning on Study Day -1 through the last blood sample collection on Study Day 9 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 28 during Period 2.

Conditions Studied

Healthy Volunteers

Interventions

  • DRUG Bardoxolone methyl capsules 10 mg
  • DRUG Itraconazole capsules 100 mg

Study Locations (1)

Ohio

  • Medpace Clinical Pharmacology Unit - Cincinnati

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2017-10-16
Est. Completion 2017-11-13
Phase Phase 1

Sponsor

Biogen

334 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03264079

The ClinicalTrials.gov registry entry for NCT03264079 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Bardoxolone methyl capsules 10 mg is the first listed.

NCT03264079 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT03264079 about?

NCT03264079 is a clinical study titled "Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults". This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects. This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy volunteers. Subjects will complete a screening visit...

What is the current status of trial NCT03264079?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2017-10-16. Estimated completion is 2017-11-13.

What conditions does trial NCT03264079 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT03264079?

The interventions under investigation include: Bardoxolone methyl capsules 10 mg (DRUG), Itraconazole capsules 100 mg (DRUG).

Who is sponsoring clinical trial NCT03264079?

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

Where is trial NCT03264079 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.