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Early-Stage Study of Afimkibart for Ulcerative Colitis

This study is looking at how a medicine called afimkibart might affect how your body processes other common medicines, like caffeine, warfarin, omeprazole, and dextromethorphan. This is important because many medicines are broken down by special proteins in your body called cytochrome P450 (CYP) enzymes. Researchers want to see if afimkibart changes how these other medicines work in people with moderately to severely active ulcerative colitis (UC). The study aims to understand how much of these medicines are in your blood and for how long, both with and without afimkibart. You may be able to join if you are between 18 and 60 years old, weigh at least 40kg, and have a confirmed diagnosis of active UC. The study plans to enroll 25 participants.

Study design
This is an early-stage interventional study planning to enroll 25 participants. It will involve giving participants afimkibart and a combination of other medicines to see how they interact.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for this study will be taken for up to approximately 13 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07665723

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

Recruiting
PHASE1Ages 18–60InterventionalTreatment
Hoffmann-La Roche
~25 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:AfimkibartCaffeineWarfarinOmeprazoleDextromethorphanMidazolam

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Up to approximately 13 weeks
+7 more outcomes measured

Conditions

Active Ulcerative Colitis

Explore related trials

Ulcerative Colitis

Where it's being run

17 sites across 6 states
Poland8
United Kingdom3
Florida2
Belgium2
California1
Germany1

Who to contact

Reference Study ID Number : GA46438 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Body weight \>= 40kg
Agreement to adhere to the contraceptive requirements
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

Exclusion

Current diagnosis of Crohn's disease (CD),abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
Presence of an ostomy or ileoanal pouch
Current diagnosis or suspicion of primary sclerosing cholangitis
Lack of peripheral venous access
Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
History of alcohol, drug, or chemical abuse \< 1 year prior to screening

What this trial measures

  • 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)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, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)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
  • Time to Maximum Concentration (Tmax) 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
  • Elimination Half-life (T1/2) 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
  • Metabolite-to-parent Area Under the Curve From Time 0 (AUC0-t) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine)Up to approximately 13 weeks
  • Metabolite-to-parent Area Under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine)Up to approximately 13 weeks
  • Metabolite-to-parent Concentration of CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine)Up to approximately 13 weeks