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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

RecruitingPhase 1Ages 18 Years - 60 YearsAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Afimkibart
  • Caffeine
  • Warfarin
  • Omeprazole
  • Dextromethorphan
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Where

18 sites
Erick H. Alayo Medical Corporation - Gastro SB Clinic
Chula Vista, United States
Allied Biomedical Research Institute, Inc
Miami, United States
Gastro Health Research
Miami, 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

โ€ฆand 10 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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