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

Phase 1RecruitingNCT06379958

Modern Biosciences Ltd48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pharmacokinetics

Interventions

leramistat 40mgDRUG

Oral capsule

Itraconazole 200 mgDRUG

Oral capsule

Phenytoin 100 Mg Oral CapsuleDRUG

Oral capsule

Simvastatin 40mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion

Belfast, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

leramistat: Area under the curve - AUC0-t

Time frame: 8.5 Weeks

leramistat: Area under the curve - AUC0-24h

Time frame: 8.5 Weeks

leramistat: Area under the curve - AUC0-inf

Time frame: 8.5 weeks

leramistat: Maximum observed concentration - Cmax

Time frame: 8.5 weeks

leramistat: Time of the maximum observed concentration - Tmax

Time frame: 8.5 weeks

leramistat:Elimination rate constant -Kel

Time frame: 8.5 weeks

leramistat: Half life - t½

Time frame: 8.5 weeks

leramistat: Plasma Clearance -CL/F

Time frame: 8.5 weeks

leramistat: Volume of distribution - Vz/F

Time frame: 8.5 weeks

Secondary Outcomes

Incidence of adverse event.

Time frame: 8.5 weeks

Central Contacts

Study Team

CONTACT

+44 (0)207 444 0066 ist05@istesso.co.uk

Data from ClinicalTrials.gov

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