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An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
Sponsor: Hoffmann-La Roche
Summary
The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121). This will be assessed by the characterization of the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates alone and after administration of afimkibart in participants with moderately to severely active ulcerative colitis (UC).
Official title: A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates After Treatment With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-06-30
Completion Date
2030-12-31
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Interventions
Afimkibart
Afimkibart will be administered as per the schedule defined in the protocol.
Caffeine
Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Warfarin
Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Omeprazole
Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Dextromethorphan
Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Midazolam
Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Vitamin K
Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.
Locations (6)
Erick H. Alayo Medical Corporation - Gastro SB Clinic
Chula Vista, California, United States
Gastro Health Research
Miami, Florida, United States
Charite Research Organisation GmbH
Berlin, Germany
Royal Liverpool University Hospital
Liverpool, United Kingdom
University College London Hospitals
London, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom