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

Sponsor
Modern Biosciences Ltd
Study ID
NCT06379958
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • leramistat 40mg — DRUG
    Oral capsule
  • Itraconazole 200 mg — DRUG
    Oral capsule
  • Phenytoin 100 Mg Oral Capsule — DRUG
    Oral capsule
  • Simvastatin 40mg — DRUG
    Oral capsule
  • Upadacitinib 15 MG — DRUG
    Oral Capsule

Study Details

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

Key Dates

Start date
Apr 8, 2024
Status verified
Aug 2024
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Part 1: Itraconazole 200mg
  • Active Comparator: Part 2: Phenytoin 100mg
  • Active Comparator: Part 3: Simvastatin 40mg
  • Active Comparator: Part 4: Upadacitinib 15 mg

Primary Outcome Measure

leramistat: Area under the curve - AUC0-t [ Time Frame: 8.5 Weeks ]

Central Contacts

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