JZP441 Safety Study in Healthy Participants

Overseen By Clinical Trial Disclosure & Transparency

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Jazz Pharmaceuticals

Must not be taking: Antidepressants, Benzodiazepines, Kratom, others

Disqualifiers: Cardiovascular disease, Depression, Bipolar, Schizophrenia, Substance use, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called JZP441, which helps people stay awake and prevents sudden muscle weakness. It is aimed at people with narcolepsy and hypersomnolence disorders who struggle with these symptoms. The study will check the safety and effectiveness of the drug in healthy adults over a short period.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes participants who are taking medications or supplements that lower seizure threshold or have recently stopped such medications. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug JZP441?

Research on similar drugs, known as Janus kinase inhibitors, shows they can be effective in treating conditions like rheumatoid arthritis by reducing symptoms quickly. This suggests that JZP441, if it works similarly, might also be effective. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-50 with no gastrointestinal, liver, or kidney diseases that could affect drug processing. They must not have a history of substance abuse in the past two years and should not be using any medications that lower seizure threshold.

Inclusion Criteria

I am generally healthy as confirmed by a full medical check-up.

Exclusion Criteria

I have used tobacco or nicotine products within the last 90 days or heavily in the past year.

My ECG shows a QT interval longer than normal or other significant issues.

My kidney function is reduced with an eGFR below 80 mL/min.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending doses of JZP441 or placebo for up to 4 weeks

4 weeks

Pre-dose and multiple post-dose timepoints

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JZP441

Trial Overview The study tests JZP441's safety and how it's processed by the body when given in increasing doses to healthy participants. It compares JZP441 against a placebo to see if it can help people with narcolepsy without causing harm.

How Is the Trial Designed?

Group I: JZP441 Experimental Treatment 1 Intervention

Healthy participants who will be randomized to receive an oral dose of JZP441.

Group II: Placebo Placebo Group 1 Intervention

Healthy participants who will be randomized to receive placebo.

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

In a study of 10 patients with juvenile dermatomyositis (JDM) treated with Janus kinase inhibitors (JAKis) for at least 6 months, 5 patients achieved clinically inactive disease, indicating that JAKis can be effective for refractory cases.

While JAKis showed promise in improving muscle vasculopathy and reducing steroid use, there was a notable risk of herpes zoster infections in some patients, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

JAK inhibitors are effective in a subset of patients with juvenile dermatomyositis: a monocentric retrospective study. Le Voyer, T., Gitiaux, C., Authier, FJ., et al.[2021]

Janus kinase inhibitors, including new compounds like filgotinib and upadacitinib, show promising fast and dose-dependent clinical improvements in treating rheumatoid arthritis, comparable to existing treatments like tofacitinib and baricitinib.

While these new drugs have similar adverse events, some side effects are specific to individual drugs, highlighting the need for thorough phase III trials and safety evaluations to optimize their use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of new JAK inhibitors under development. Just more of the same? Westhovens, R.[2023]

In a phase III study involving 507 patients with rheumatoid arthritis, peficitinib (100 mg and 150 mg once daily) significantly improved symptoms compared to placebo, with ACR20 response rates of 57.7% and 74.5% respectively at week 12.

Peficitinib was well tolerated overall, although there was a higher incidence of serious infections and herpes zoster compared to placebo, indicating a need for monitoring but no clear dose-dependent increase in adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3). Tanaka, Y., Takeuchi, T., Tanaka, S., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

JAK inhibitors are effective in a subset of patients with juvenile dermatomyositis: a monocentric retrospective study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Clinical efficacy of new JAK inhibitors under development. Just more of the same? [2023]

3. England pubmed.ncbi.nlm.nih.gov

Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of a Janus kinase 1 inhibitor, PF-04965842, in healthy subjects: A phase 1, randomized, placebo-controlled, dose-escalation study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3). [2020]