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

Modern Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Simvastatin 40mg; Drug: Itraconazole 200 mg; Drug: Upadacitinib 15 MG; Drug: Phenytoin 100 Mg Oral Capsule; Drug: leramistat 40mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06379958

IST-05

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Part 1: Itraconazole 200mg

Active Comparator group

Treatment:

Drug: leramistat 40mg

Drug: Itraconazole 200 mg

Part 2: Phenytoin 100mg

Active Comparator group

Treatment:

Drug: leramistat 40mg

Drug: Phenytoin 100 Mg Oral Capsule

Part 3: Simvastatin 40mg

Active Comparator group

Treatment:

Drug: leramistat 40mg

Drug: Simvastatin 40mg

Part 4: Upadacitinib 15 mg

Active Comparator group

Treatment:

Drug: leramistat 40mg

Drug: Upadacitinib 15 MG