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
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
Hoffmann-La Roche
25 participants
Jun 29, 2026
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
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Interventions
Afimkibart will be administered as per the schedule defined in the protocol.
Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.
Locations(7)
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NCT07665723