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

M

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

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)

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

Trial contacts and locations

1

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Central trial contact

Study Team

Data sourced from clinicaltrials.gov

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