Clinical trial NCT05927649: A TQTc Study for Omaveloxolone
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study in Healthy Subjects to Determine the Effect of Omaveloxolone on QTc Interval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health Adult Subjects
Keywords: C-QTc
omaveloxolone
TWTc
moxifloxacin
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Celerion
name: Q2 Solutions
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Omaveloxolone and placebo will be administered in a blinded fashion. All treatments will be administered after an FDA high-fat meal. Concentration-QTc (C-QTc) analysis is the primary analysis for the study.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening.
* BMI at screening between 18.0 and 32.0 kg/m2 (inclusive)
* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

* History of clinically significant drug allergies, including allergies to any of the components of the study drugs (omaveloxolone and moxifloxacin) and/or clinically significant food allergies as determined by the investigator.
* Subject has an ECG abnormality, including corrected QT interval (QTc)\> 450 msec for males, and \> 460 msec for females, HR \< 45 bpm or \> 100 bpm after 5 minutes in supine position, PR interval \> 220 msec, or QRS interval \> 110 msec.
* Subject has allergy to band aids, adhesive dressing, or medical tape.
* Subject has hypotension (systolic blood pressure blood pressure \[BP\] ≤ 90 mmHg, diastolic BP ≤ 50 mmHg), or hypertension (systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg) at screening.
* Subject has history of prolonged QTc, cardiac arrhythmia, or first-degree relatives with congenital Long QT syndrome or unexplained sudden death in young age.
* Subject has a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure (CHF), transient ischemic attack (TIA), or neurological disorder.
* Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator.
* Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
* Requirement for any over the counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis
* Use of any medications (over the counter and/or prescription medication), vitamins, and/or herbal supplements, within the 14-days prior to study drug administration or within 5 halflives (if known), whichever is longer
* History of drug or alcohol abuse in the last 6 months as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.
* Positive test result for drugs of abuse, alcohol, or cotinine at screening or Day -1.
* Positive test result for hepatitis B surface antigen, hepatitis C virus antibodies, or HIV antibodies at screening.
* Positive test result for COVID-19 at Day -1.
* Blood donation (excluding plasma donation) of approximately 500 mL within 56 days before screening or plasma donation within 7 days before screening.
* Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days before study drug administration.
* Consumption of alcohol within 72 hours before study drug administration.
* Consumption of grapefruit, grapefruit products, star fruit, star fruit products, Seville oranges, or Seville orange products within the 72-hour period before study drug administration.
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
* Current enrollment in another clinical study.
* Previous enrollment in any clinical study involving omaveloxolone.

Primary outcomes:
measure: Change from baseline in placebo-corrected QTcF (∆∆QTcF)
timeFrame: At Day 1 of each period, which is 14 days for both Treatment A and Treatment B and 4 days for Treatment C
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc.
state: Arizona
Study officials:
affiliation: Celerion
name: Michelle Valentine, DO
role: PRINCIPAL_INVESTIGATOR
References: