Clinical trial NCT03931590: A Human AME Study for Omaveloxolone
Official title: Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Keywords: RTA 408
RTA 408 capsules
omaveloxolone
omaveloxolone capsules
AME
mass balance
metabolite identification
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2019-04-30
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Maximum concentration (Cmax) of omaveloxolone
timeFrame: 22 days
measure: Area under the omaveloxolone concentration-time curve (AUC)
timeFrame: 22 days
measure: Maximum concentration of total radioactivity in blood and plasma
timeFrame: 22 days
measure: Area under the concentration-time curve total radioactivity in blood and plasma
timeFrame: 22 days
measure: Amount of radioactivity excreted in urine (Aeu)
timeFrame: 22 days
measure: Amount of radioactivity excreted in feces (Aef)
timeFrame: 22 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit (CRU) Inc.
state: Wisconsin
Study officials:
affiliation: Covance CRU Inc.
name: Nicholas Siebers, MD
role: PRINCIPAL_INVESTIGATOR
References: