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

Conditions

• Active Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Afimkibart — DRUG
  Afimkibart will be administered as per the schedule defined in the protocol.
• Caffeine — DRUG
  Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
• Warfarin — DRUG
  Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
• Omeprazole — DRUG
  Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
• Dextromethorphan — DRUG
  Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
• Midazolam — DRUG
  Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
• Vitamin K — OTHER
  Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.

Study Details

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).

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

Jul 31, 2027

Completion

Dec 31, 2030

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Afimkibart Treatment and CYP Cocktail Group
  Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.

Primary Outcome Measure

Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t [AUC last]) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) [ Time Frame: Up to approximately 13 weeks ]

Central Contacts

• Reference Study ID Number : GA46438 https://forpatients.roche.com/
  888-662-6728 (U.S. Only)
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (2)

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