Afimkibart and how it affects other medicines in people with ulcerative colitis
Tests how afimkibart changes the body's handling of other medicines in ulcerative colitis.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Berlin, GermanySee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07665723, who can take part
Where in Germany
- Charite Research Organisation GmbHBerlin, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07665723EU 2025-524060-38-00
- Record updated
- 16 October 2026
- Original 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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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; 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.