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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

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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