Examining how Leramistat interacts with other drugs in healthy adults
A Phase 1, Open-label, 4-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat, to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin, and to Evaluate the Pharmacokinetic Interaction Between Leramistat and Upadacitinib (RINVOQ®) in Healthy Adult Subjects
This study is testing how the drug Leramistat works with other medications in healthy adults to see if they affect each other and to check for any side effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Modern Biosciences Ltd Industry-sponsored |
| Locations | 1 site (Belfast) |
| Trial ID | NCT06379958 on ClinicalTrials.gov |
What this trial studies
This study investigates the drug-drug interactions (DDI) of Leramistat in healthy adult participants through an open-label, fixed-sequence design. It consists of four parts, where subjects will receive Leramistat alongside other medications such as Itraconazole, Phenytoin, and Simvastatin to assess how these drugs affect each other's pharmacokinetics. The study aims to gather data on the safety and efficacy of these interactions in a controlled environment. Participants will be closely monitored for any adverse effects during the study.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 years, both male and female, who are not of childbearing potential.
Not a fit: Patients with significant medical or psychiatric conditions that could confound study results or pose additional risks will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how Leramistat interacts with other medications, leading to safer prescribing practices.
How similar studies have performed: While this specific approach may be novel, drug-drug interaction studies are a common practice in pharmacokinetics, and previous studies have shown success in understanding medication interactions.
Eligibility criteria
Show full inclusion / exclusion criteria
Principal Inclusion Criteria: Healthy, adult, male or female of non childbearing potential 18 to 55 years of age. Principal Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Where this trial is running
Belfast
- Celerion — Belfast, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Study Team
- Email: ist05@istesso.co.uk
- Phone: +44 (0)207 444 0066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.