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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

Hoffmann-La Roche · NCT07665723

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
25
US sites recruiting
3
Study start
June 29, 2026
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Afimkibart; Caffeine; Warfarin; Omeprazole; Dextromethorphan; Midazolam; Vitamin K

Conditions: Active Ulcerative Colitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Erick H. Alayo Medical Corporation - Gastro SB Clinic

    Chula Vista, CA 91910

  • Allied Biomedical Research Institute, Inc

    Miami, FL 33155

  • Gastro Health Research

    Miami, FL 33176-2416

Study contacts (from the official record)

  • Reference Study ID Number : GA46438 https://forpatients.roche.com/ No attachments to email below. · 888-662-6728 (U.S. Only) · global-roche-genentech-trials@gene.com
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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An Early-Stage Study in Multiple Clinics of How Afimkibart May… (NCT07665723) | Bored Studies