A Human AME Study for Omaveloxolone

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931590
• Other study ID #: 408-C-1805
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2019
• Est. completion date: May 31, 2019

Study information

• Verified date: February 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• [14C]-Omaveloxolone
[14C]-Omaveloxolone 50 mg capsules

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit (CRU) Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax) of omaveloxolone	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).	22 days
Primary	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
Primary	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
Primary	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
Primary	Amount of radioactivity excreted in urine (Aeu)	Rates and routes of elimination will be assessed by urine sampling for radioactivity.	22 days
Primary	Amount of radioactivity excreted in feces (Aef)	Rates and routes of elimination will be assessed by sampling of feces for radioactivity.	22 days