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Completed

NCT Number: NCT03931590

A Human AME Study for Omaveloxolone

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.

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Key information

Conditions

Healthy Male Subjects

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit (CRU) Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C]-Omaveloxolone

Drug

[14C]-Omaveloxolone 50 mg capsules

Other names: [14C]-RTA 408

Primary outcomes

  1. Maximum concentration (Cmax) of omaveloxolone

    Time frame: 22 days

    Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).

  2. Area under the omaveloxolone concentration-time curve (AUC)

    Time frame: 22 days

    Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).

  3. Maximum concentration of total radioactivity in blood and plasma

    Time frame: 22 days

    Mass balance and metabolite profiles will be assessed by blood sampling for omaveloxolone to determine maximum concentration of total radioactivity

  4. Area under the concentration-time curve total radioactivity in blood and plasma

    Time frame: 22 days

    Mass balance and metabolite profiles will be assessed by blood sampling for total radioactivity to determine area under the concentration-time curve.

  5. Amount of radioactivity excreted in urine (Aeu)

    Time frame: 22 days

    Rates and routes of elimination will be assessed by urine sampling for radioactivity.

  6. Amount of radioactivity excreted in feces (Aef)

    Time frame: 22 days

    Rates and routes of elimination will be assessed by sampling of feces for radioactivity.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2019
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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