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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHoffmann-La Roche

About this trial

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

Qualifiers

Body weight >= 40kg

Agreement to adhere to the contraceptive requirements

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

Disqualifiers

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

Lack of peripheral venous access

Trial design

Treatments tested in this trial

  • Afimkibart
  • Caffeine
  • Warfarin
  • Omeprazole
  • Dextromethorphan
  • Midazolam
  • Vitamin K

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators