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Recruiting

A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam - IM026-026

Opdateret: 12 juli, 2023   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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Forsøgsdetaljer

  • Phase 1

    Fase

  • Køn

  • 18-55

    Aldersinterval

  • 1

    Beliggenhed(er)

  • Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Part 1: Afimetoran followed by phenytoin + afimetoran
Drug: Phenytoin, Afimetoran
Experimental: Part 2: Midazolam followed by afimetoran + midazolam
Drug: Midazolam, Afimetoran

Primære egnethedskriterier

Inclusion Criteria: - Body mass index (BMI) of 19.0 kilograms per meter squared (kg/m^2) to 32.0 kg/m2, inclusive, and body weight ≥ 55 kg, at screening. Exclusion Criteria: - Any significant acute or chronic medical illness or any other condition listed as a contraindication in the phenytoin (Part 1) or midazolam (Part 2) package inserts. - History of seizure (including simple febrile seizure), epilepsy, severe head injury (including concussion), multiple sclerosis, or other known neurological condition which the investigator considers to be clinically significant. - Current or recent (within 3 months of study intervention administration) GI disease that could impact upon the absorption of study intervention. Other protocol-defined inclusion/exclusion criteria apply.

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