How the body handles BIIB141 (omaveloxolone) as a dissolvable tablet versus a capsule in healthy adults

A Phase 1, Randomized, Open-Label, Single-Dose, Crossover, Bioequivalence Study of Omaveloxolone Tablets for Oral Suspension Versus Capsules in Healthy Adult Participants

This study will test whether taking BIIB141 (omaveloxolone) as a tablet dissolved in liquid leads to the same drug levels in the body as taking it as a capsule in healthy adults aged 18 to 55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Biogen (Industry-sponsored)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT07297199 on ClinicalTrials.gov

What this trial studies

Healthy adult volunteers will receive a single dose of omaveloxolone either as the marketed capsule or as a tablet for oral suspension and blood levels will be measured over time to determine bioequivalence. The primary measure is pharmacokinetic comparison between the two formulations. Safety and tolerability will be tracked by monitoring adverse events, vital signs, labs, and ECGs. The trial is conducted at a clinical research unit in Austin, Texas under Biogen sponsorship.

Who should consider this trial

Good fit: Healthy adults aged 18 to 55 with a BMI between 18 and 32 kg/m^2 who pass screening (including negative pregnancy tests for women of childbearing potential) and have no major medical conditions are ideal candidates.

Not a fit: People with active medical conditions, pregnant women, or patients with Friedreich's ataxia should not expect direct therapeutic benefit from this single-dose healthy-volunteer bioequivalence study.

Why it matters

Potential benefit: If successful, a dissolvable tablet could offer an easier way to take omaveloxolone for people who have trouble swallowing capsules while providing the same treatment exposure.

How similar studies have performed: Formulation-switch bioequivalence studies are common and often demonstrate equivalent exposure, and omaveloxolone is already approved in capsule form so this is a routine formulation comparison.

Eligibility criteria

Key Inclusion Criteria:

* All female participants of childbearing potential must have negative results for pregnancy tests as follows:

  1. At screening, based on a serum sample obtained within 28 days prior to initial study drug administration; and
  2. Prior to dosing, based on a serum sample obtained on Study Day -1.
* Body Mass Index (BMI) at screening between 18 and 32 kilograms per meter square (kg/m\^2), inclusive.
* Participants must be in good health.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* Clinically significant, as determined by the Investigator, 12-lead electrocardiogram (ECG) abnormalities.
* History of, or positive test result for human immunodeficiency virus (HIV).
* History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody (HCV Ab).
* Current hepatitis B infection \[defined as positive for hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody (anti-HBc)\]. Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-HBs) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study.
* Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
* Prior exposure to the study treatment.
* Any clinically significant abnormal laboratory test value as determined by the Investigator, as Screening or Day-1.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Austin, Texas

• Trialmed formerly PPD, Austin Clinical Research Unit — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: US Biogen Clinical Trial Center

Conditions Healthy Volunteer