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RECRUITING Phase 1 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07665723

Registry updated: 2026-10-16
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Description

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).

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.

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: Inflammatory Bowel Disease (IBD) Exclusion Criteria: * 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 Medical History Exclusion Criteria: * 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

Conditions

Active Ulcerative Colitis

Locations

  • Erick H. Alayo Medical Corporation - Gastro SB Clinic — Chula Vista, California, United States
  • Allied Biomedical Research Institute, Inc — Miami, Florida, United States
  • Gastro Health Research — Miami, Florida, United States
  • UZ Leuven Gasthuisberg — Leuven, Belgium
  • AZ Delta (Campus Rumbeke) — Roeselare, Belgium
  • Charite Research Organisation GmbH — Berlin, Germany
  • Centrum Medyczne "Medis" — Bydgoszcz, Poland
  • Amicare Sp. z o.o. S.K. — Lodz, Poland
  • Medrise sp z o.o — Lublin, Poland
  • Allmedica Badania Kliniczne Sp z o.o. Sp K. — Nowy Targ, Poland
  • NZOZ Eskulap Pabianice — Pabianice, Poland
  • SOLUMED Centrum Medyczne — Późna, Poland
  • Centralny Szpital Kliniczny MSW w Warszawie — Warsaw, Poland
  • WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland
  • PlanetMed sp. z o.o. — Wroc?aw, Poland
  • Royal Liverpool University Hospital — Liverpool, United Kingdom
  • University College London Hospitals — London, United Kingdom
  • Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record