RecruitingPhase 1NCT06379958

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

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


Sponsor

Modern Biosciences Ltd

Enrollment

48 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria1

  • Healthy, adult, male or female of non childbearing potential 18 to 55 years of age.

Exclusion Criteria2

  • 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.

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Interventions

DRUGleramistat 40mg

Oral capsule

DRUGItraconazole 200 mg

Oral capsule

DRUGPhenytoin 100 Mg Oral Capsule

Oral capsule

DRUGSimvastatin 40mg

Oral capsule

DRUGUpadacitinib 15 MG

Oral Capsule


Locations(1)

Celerion

Belfast, United Kingdom

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NCT06379958


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