New Formulations of TEV-56286 for Healthy Subjects

Overseen By Teva U.S. Medical Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Teva Branded Pharmaceutical Products R&D LLC

Disqualifiers: Alcohol, Drug abuse, Arrhythmia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 25 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how the body absorbs different formulations of a drug called TEV-56286 in healthy adults. Researchers also seek to assess the safety and tolerability of these formulations. Participants will try both new and existing versions of the drug. The trial seeks healthy individuals with a body mass index (BMI) between 18.5 and 32 who have not recently participated in another trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug formulation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please contact the investigator for more details.

Is there any evidence suggesting that TEV-56286 is likely to be safe for humans?

Research has shown that TEV-56286, also known as emrusolmin, is under study for its safety and effectiveness. The FDA has granted it Fast Track designation for Multiple System Atrophy, a rare brain disorder, indicating promise in earlier tests.

As this trial is in its early stages, detailed information on tolerance is limited. In this Phase 1 trial, the primary goal is to assess safety in healthy volunteers. Researchers closely monitor responses to the drug, including any side effects.

In summary, while the FDA's Fast Track designation is encouraging, more information will emerge as the trial progresses. Participants receive close monitoring to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TEV-56286 because it offers a new formulation that might improve how the body absorbs the medication. Unlike current treatments for similar conditions that may have slower or less predictable absorption, TEV-56286 is designed to enhance bioavailability, potentially leading to quicker and more consistent effects. This could mean faster relief for patients and more reliable outcomes, setting it apart from existing options.

What evidence suggests that TEV-56286 might be an effective treatment?

Research has shown that TEV-56286 is being tested as a treatment for multiple system atrophy (MSA), a rare brain disorder. In one study, 71.4% of MSA patients showed improvement after receiving a high dose of intravenous amantadine, a component of the treatment, for five days. This suggests that TEV-56286 might help improve MSA symptoms. While the current trial focuses on evaluating how well TEV-56286 is absorbed in different formulations, earlier studies suggest it could be beneficial. ^{6 7 8 9 10}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI of 18.5 to 32 who agree to prevent pregnancy during the study. Men must use contraception unless they are sterile. People can't join if they have a history of heart issues, are in another trial, have substance abuse within the last year, donated blood recently or plan surgery.

Inclusion Criteria

Body mass index (BMI) between 18.5 kg/m2 to 32.0 kg/m2 (inclusive)

I agree to use birth control during the study.

I am a male willing to use contraception if I'm not sterile.

Exclusion Criteria

I or my family have a history of heart rhythm problems or sudden deaths before 40.

Participation in another clinical trial simultaneously

History of alcohol, drug or any other substance, abuse, addiction or dependence in the last 12 months (except for caffeine)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

45 days

Treatment

Participants receive single-dose administration of TEV-56286 test and reference formulations in a randomized crossover design

Approximately 25 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TEV-56286

Trial Overview

The study tests how the body absorbs two versions of TEV-56286: one already known (reference) and one new (test). It checks which formulation enters the bloodstream better over approximately 70 days including screening and follow-up.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 2 Interventions

Random sequence of test and reference formulations

Group II: Cohort 1 Experimental Treatment 2 Interventions

Random sequence of test and reference formulations

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D LLC

Lead Sponsor

Published Research Related to This Trial

A systematic review of 21 trials involving 3,644 patients found that endothelin receptor antagonists, particularly bosentan, significantly increase the risk of hepatotoxicity, with a relative risk of 2.92 for any hepatic adverse reaction.

When hepatotoxicity was specifically defined as liver enzyme elevations three times above normal, the relative risk rose to 2.98, indicating a concerning safety profile for these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hepatotoxicity in patients treated with endothelin receptor antagonists: systematic review and meta-analysis of randomized clinical trials]. Macías Saint-Gerons, D., de la Fuente Honrubia, C., Montero Corominas, D., et al.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06568237

NCT06568237 | A Study to Test if TEV-56286 is Effective in ...

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System ...

2.

tevapharm.com

tevapharm.com/teva-clinical-trials/clinical-trials-results/

Clinical Trials – Results

A Study to Assess New Formulations of TEV-56286. brain ... 56286 test formulations compared to TEV-56286 reference product in healthy adult participants.

3.

neurologylive.com

neurologylive.com/view/teva-emrusolmin-granted-fast-track-designation-multiple-system-atrophy

Teva's Emrusolmin Granted Fast Track Designation for ...

2. A study to test if TEV-56286 is effective in relieving multiple system atrophy (MSA): a safety and efficacy study (TOPAS-MSA).

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07197866

NCT07197866 | An Extension Trial to Test if TEV-56286 is ...

A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: ...

5.

withpower.com

withpower.com/trial/tev-56286-for-multiple-system-atrophy-9dcac

TEV-56286 for Multiple System Atrophy (TOPAS-MSA Trial)

In a study of 14 patients with multiple system atrophy parkinsonism (MSA-P), high-dose intravenous amantadine for 5 days led to clinical improvement in 71.4% of ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06911567

A Study to Assess New Formulations of TEV-56286

The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy ...

7.

tevapharm.com

tevapharm.com/news-and-media/latest-news/tevas-emrusolmin-granted-u.s.-fda-fast-track-designation-for-treatment-of-multiple-system-atrophy

Teva's Emrusolmin Gets FDA Fast Track for MSA Treatment

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for ...

8.

trialx.com

trialx.com/clinical-trials/listings/296458/a-study-to-assess-new-formulations-of-tev-56286/

A Study to Assess New Formulations of TEV-56286

The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy ...

9.

uspharmacist.com

uspharmacist.com/article/emrusolmin-fda-fast-tracked-for-multiple-system-atrophy

Emrusolmin FDA Fast Tracked for Multiple System Atrophy

Teva Pharmaceuticals Industries Ltd announced that the FDA granted Fast Track designation for Teva's investigational therapy emrusolmin ...

10.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06568237

NCT06568237 | A Study to Test if TEV-56286 is Effective in ...

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System ...