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

NCT ID: NCT06379958

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2024-09-30

Brief Summary

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

Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Part 1: Itraconazole 200mg

Group Type ACTIVE_COMPARATOR

leramistat 40mg

Intervention Type DRUG

Oral capsule

Itraconazole 200 mg

Intervention Type DRUG

Oral capsule

Part 2: Phenytoin 100mg

Group Type ACTIVE_COMPARATOR

leramistat 40mg

Intervention Type DRUG

Oral capsule

Phenytoin 100 Mg Oral Capsule

Intervention Type DRUG

Oral capsule

Part 3: Simvastatin 40mg

Group Type ACTIVE_COMPARATOR

leramistat 40mg

Intervention Type DRUG

Oral capsule

Simvastatin 40mg

Intervention Type DRUG

Oral capsule

Part 4: Upadacitinib 15 mg

Group Type ACTIVE_COMPARATOR

leramistat 40mg

Intervention Type DRUG

Oral capsule

Upadacitinib 15 MG

Intervention Type DRUG

Oral Capsule

Interventions

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leramistat 40mg

Oral capsule

Intervention Type DRUG

Itraconazole 200 mg

Oral capsule

Intervention Type DRUG

Phenytoin 100 Mg Oral Capsule

Oral capsule

Intervention Type DRUG

Simvastatin 40mg

Oral capsule

Intervention Type DRUG

Upadacitinib 15 MG

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Modern Biosciences Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celerion

Belfast, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Study Team

Role: CONTACT

+44 (0)207 444 0066

Facility Contacts

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Phase 1 Unit

Role: primary

Other Identifiers

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IST-05

Identifier Type: -

Identifier Source: org_study_id

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