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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

NCT07665723 · Hoffmann-La Roche
In plain English

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Official title
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
About this study
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 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
Study design
Enrollment target: 25 participants
Allocation: na
Masking: none
Age groups: adult
Timeline
Starts: 2026-06-30
Estimated completion: 2030-12-31
Last updated: 2026-06-24
Interventions
Drug: AfimkibartDrug: CaffeineDrug: WarfarinDrug: OmeprazoleDrug: DextromethorphanDrug: MidazolamOther: Vitamin K
Primary outcomes
  • 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)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number : GA46438 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
ContactFastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry · contact
All locations (6)
Erick H. Alayo Medical Corporation - Gastro SB ClinicRecruiting
Chula Vista, California, United States
Gastro Health ResearchRecruiting
Miami, Florida, United States
Charite Research Organisation GmbHRecruiting
Berlin, Germany
Royal Liverpool University HospitalRecruiting
Liverpool, United Kingdom
University College London HospitalsRecruiting
London, United Kingdom
Royal Victoria InfirmaryRecruiting
Newcastle upon Tyne, United Kingdom
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 · TrialPath