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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 18, 2020
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE April 11, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Maximum concentration (Cmax) of omaveloxolone [ Time Frame: 22 days ]
    Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
  • 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).
  • 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
  • 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.
  • Amount of radioactivity excreted in urine (Aeu) [ Time Frame: 22 days ]
    Rates and routes of elimination will be assessed by urine sampling for radioactivity.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Human AME Study for Omaveloxolone
Official Title  ICMJE Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Male Subjects
Intervention  ICMJE Drug: [14C]-Omaveloxolone
[14C]-Omaveloxolone 50 mg capsules
Other Name: [14C]-RTA 408
Study Arms  ICMJE 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.
Intervention: Drug: [14C]-Omaveloxolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2019)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931590
Other Study ID Numbers  ICMJE 408-C-1805
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Reata Pharmaceuticals, Inc.
Study Sponsor  ICMJE Reata Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicholas Siebers, MD Covance CRU Inc.
PRS Account Reata Pharmaceuticals, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP