A Human AME Study for Omaveloxolone

Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects

This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of [14C] omaveloxolone and derived metabolites following administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: [14C]-Omaveloxolone

Detailed Description

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit (CRU) Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated:
• Males, of any race, between 18 and 55 years of age, inclusive.
• Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, and a total body weight > 50 kg.
• Be surgically sterile or willing to agree to use contraception
• In good health, as assessed by the investigator (or designee).
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

• Significant history or clinical manifestation of any major system disorder, as determined by the investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
• Presence of any other condition, including surgery, known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
• Abnormal laboratory values considered clinically significant by the investigator.
• Clinically significant abnormal 12-lead ECGs.
• History of alcoholism or drug/chemical abuse within 2 years prior to Check-in (Day-1).
• Alcohol consumption of > 21 units per week.
• Positive urine drug screen at Screening, or positive alcohol breath test result or positive urine drug screen at Check-in (Day -1).
• Positive hepatitis panel and/or positive human immunodeficiency virus test.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing.
• Current enrollment in another clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Male Subjects; Single oral dose of 150 mg of [14C] omaveloxolone containing approximately 90 μCi as a capsule after an overnight fast of at least 10 hours.	Drug: [14C]-Omaveloxolone; [14C]-Omaveloxolone 50 mg capsules; Other Names: [14C]-RTA 408

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration (Cmax) of omaveloxolone	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).	22 days
Area under the omaveloxolone concentration-time curve (AUC)	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).	22 days
Maximum concentration of total radioactivity in blood and plasma	Mass balance and metabolite profiles will be assessed by blood sampling for omaveloxolone to determine maximum concentration of total radioactivity	22 days
Area under the concentration-time curve total radioactivity in blood and plasma	Mass balance and metabolite profiles will be assessed by blood sampling for total radioactivity to determine area under the concentration-time curve.	22 days
Amount of radioactivity excreted in urine (Aeu)	Rates and routes of elimination will be assessed by urine sampling for radioactivity.	22 days
Amount of radioactivity excreted in feces (Aef)	Rates and routes of elimination will be assessed by sampling of feces for radioactivity.	22 days

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Principal Investigator: Nicholas Siebers, MD, Covance CRU Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: RTA 408; omaveloxolone; mass balance; RTA 408 capsules; omaveloxolone capsules; AME; metabolite identification
• Other Study ID Numbers: 408-C-1805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No