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

In plain English

What this trial is testing

This study is testing Afimkibart (a drug), Caffeine (a drug), Warfarin (a drug) and Omeprazole (a drug) as a possible treatment. Condition(s) listed: Active Ulcerative Colitis.

It is open-label: participants know what they are receiving.

Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.

Who can join

• Ages 18 to 60
• Any sex

Some of the main requirements, copied from the record:

• Body weight >= 40kg
• Agreement to adhere to the contraceptive requirements
• UC Specific Inclusion Criteria:
• Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence
• Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending >=15 cm from the anal verge
• Moderately to severely active UC, defined as an modified Mayo score of 5 to 9 points, including a Mayo endoscopic subscore of 2 or 3, confirmed through centrally read endoscopy

There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 25 participants are expected to take part.
• The study has 1 group.
• Start date: 2026-06-29.
• Main results expected around 2027-07-31 (estimate from the record).
• 18 study sites listed (18 marked recruiting) in Belgium, Germany, Poland, United Kingdom and United States.

Groups in this study

• Afimkibart Treatment and CYP Cocktail Group (listed as: experimental group)

Main thing being measured

• 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,… (Up to approximately 13 weeks)
• Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan,… (Up to approximately 13 weeks)
• Maximum Plasma Concentration (Cmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) (Up to approximately 13 weeks)

In the researchers’ words

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).

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.