NCT07665723PHASE1Recruiting
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
Hoffmann-La Roche
Start Date
6/29/2026
Completion Date
12/31/2030
Summary
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
Age Range: 18 years to 60 years
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
Interventions
DRUG
Afimkibart
DRUG
Caffeine
DRUG
Warfarin
DRUG
Omeprazole
DRUG
Dextromethorphan
DRUG
Midazolam
OTHER
Vitamin K
Conditions
Active Ulcerative Colitis
Locations
Erick H. Alayo Medical Corporation - Gastro SB Clinic
Chula Vista, California 91910
United States
Allied Biomedical Research Institute, Inc
Miami, Florida 33155
United States
Gastro Health Research
Miami, Florida 33176-2416
United States
Charite Research Organisation GmbH
Berlin, 10117
Germany
Royal Liverpool University Hospital
Liverpool, L7 8XP
United Kingdom
University College London Hospitals
London, W1T 7HA
United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
United Kingdom