A Human AME Study for Omaveloxolone

NCT03931590 | Completed Phase 1 FDA Drug

• 1 other identifier: 408-C-1805
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Male Subjects

Keywords

RTA 408; RTA 408 capsules; omaveloxolone; omaveloxolone capsules; AME; mass balance; metabolite identification

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Healthy Male Subjects

EXPERIMENTAL

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

Interventions

[14C]-Omaveloxolone DRUG

\[14C\]-Omaveloxolone 50 mg capsules

Also known as: [14C]-RTA 408

Healthy Male Subjects

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Covance Clinical Research Unit (CRU) Inc.

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Nicholas Siebers, MD

  Covance CRU Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 30, 2019
• Study Start: April 11, 2019
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)