Omaveloxolone for Drug Interaction Study

Overseen By Global Biogen Clinical Trial Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Disqualifiers: HIV, Hepatitis C, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 17 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the interaction between two drugs, BIIB141 (omaveloxolone) and omeprazole, in the body. Omaveloxolone is prescribed for Friedrich's Ataxia, while omeprazole commonly reduces stomach acid. The researchers aim to determine if BIIB141 alters the processing of omeprazole, potentially affecting its efficacy or causing side effects. Ideal candidates have been prescribed omaveloxolone and do not have significant health issues like heart disease or liver problems. Participants will stay at the research center for 17 days and engage in the study for up to 45 days. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since this is a drug interaction study, it's possible that some medications might need to be paused. Please discuss with the study team for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that omaveloxolone, whether taken alone or with other medicines, is generally well-tolerated. Studies have found that it can be safely combined with different types of drugs, suggesting it might also be safe to use with omeprazole. However, omaveloxolone interacts with many other drugs, so monitoring its use closely is important.

Notably, omaveloxolone is already approved for people with Friedrich's Ataxia, which provides some confidence about its safety. Participants in past studies reported few serious side effects, but like any medication, there is always a chance of adverse reactions. Participants must stay in touch with study doctors and report any health changes during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Omaveloxolone is unique because it offers a novel approach by targeting cellular pathways involved in oxidative stress and inflammation, which are not the primary focus of current standard treatments like omeprazole. While most treatments for conditions requiring omeprazole focus on reducing stomach acid, omaveloxolone's mechanism involves enhancing mitochondrial function and reducing oxidative damage. Researchers are excited about omaveloxolone because it could provide a complementary benefit for patients, potentially improving outcomes by addressing underlying cellular dysfunctions.

What evidence suggests that this trial's treatments could be effective?

Studies have shown that omaveloxolone, also known as SKYCLARYS®, effectively treats Friedrich's Ataxia (FA). It improves nerve function and reduces damage from harmful molecules in the body. Omaveloxolone is generally safe and well tolerated. In this trial, participants will receive omeprazole alone in one period and both omaveloxolone and omeprazole in another to study their interaction. While this study examines the interaction between omaveloxolone and omeprazole, previous research supports omaveloxolone's effectiveness in treating FA. ^{1 3 4 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 55 with a BMI between 18 and 32 kg/m^2. Participants must have normal serum samples prior to the study. It's not suitable for those who don't meet these health criteria or other specific conditions that would exclude them from safely participating.

Inclusion Criteria

Body mass index (BMI) at screening between 18 and 32 kg/m^2, inclusive

I am a woman who can have children and have tested negative for pregnancy.

Exclusion Criteria

History of or positive test result at Screening for human immunodeficiency virus (HIV)

I have had hepatitis C or tested positive for it.

I am currently infected with hepatitis B.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive omeprazole on Day 1, omaveloxolone from Days 2 to 15, and both drugs on Day 16

17 days

In-patient stay at research center

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 11 days

What Are the Treatments Tested in This Trial?

Interventions

• Omaveloxolone
• Omeprazole

Trial Overview The study tests how omaveloxolone (BIIB141) affects the processing of omeprazole in the body. All participants will take both drugs, with blood and urine samples collected to monitor effects. The open-label design means everyone knows which drugs are being taken.

How Is the Trial Designed?

Group I: Period 2: Omaveloxolone + Omeprazole Experimental Treatment 2 Interventions

Participants will receive omaveloxolone from Days 2 to 15, followed by both omaveloxolone and omeprazole on Day 16.

Group II: Period 1: Omeprazole Experimental Treatment 1 Intervention

Participants will receive a single oral dose of omeprazole on Day 1.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07149415

NCT07149415 | A Study to Learn if Taking BIIB141 ... The primary objective of this study is to assess the effect of omaveloxolone on the pharmacokinetics (PK) of omeprazole in healthy adult participants. The ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39920097/

Clinical Assessment of the Drug-Drug Interaction Potential ... Omaveloxolone was well tolerated when administered alone and in combination with the DME and DT modulators or substrates. These findings support ...

3. sigma.larvol.com sigma.larvol.com/product.php?e1=535587&tab=newstrac

Skyclarys (omaveloxolone) News Collectively, our results suggest that RTA-408 attenuates HIRI by improving liver function, and attenuating oxidative stress damage, apoptosis and inflammatory ...

4. adisinsight.springer.com adisinsight.springer.com/trials/700385969

A Phase 1, Open-Label, Single-Sequence, 2-Period, Drug ... A Phase 1, Open-Label, Single-Sequence, 2-Period, Drug-Drug Interaction Study in Healthy Participants Evaluating the Effect of Omaveloxolone ...

5. orpdl.org orpdl.org/durm/meetings/meetingdocs/2023_06_01/drafts/OmaveloxoloneNDE.pdf

New Drug Evaluation: Omaveloxolone Oral Capsules Plain Language Summary: • This review looks at evidence for the safety and effectiveness of omaveloxolone oral capsules. Omaveloxolone is the first medicine ...

6. drugs.com drugs.com/drug-interactions/omaveloxolone.html

Omaveloxolone Interactions Checker Omaveloxolone Interactions. There are 462 drugs known to interact with omaveloxolone, along with 1 disease interaction, and 1 alcohol/food interaction.