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A Human AME Study for Omaveloxolone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931590
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : January 15, 2020
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Male Subjects Drug: [14C]-Omaveloxolone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects
Actual Study Start Date : April 11, 2019
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

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 Name: [14C]-RTA 408




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931590


Locations
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United States, Wisconsin
Covance Clinical Research Unit (CRU) Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Nicholas Siebers, MD Covance CRU Inc.

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Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03931590    
Other Study ID Numbers: 408-C-1805
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: January 15, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reata Pharmaceuticals, Inc.:
RTA 408
RTA 408 capsules
omaveloxolone
omaveloxolone capsules
AME
mass balance
metabolite identification