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
Recruiting · NCT07665723 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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).
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
17 locations listed across 2 US states.
- Erick H. Alayo Medical Corporation - Gastro SB Clinic - Chula Vista, California, United States
- Allied Biomedical Research Institute, Inc - Miami, Florida, United States
- Gastro Health Research - Miami, Florida, United States
- Charite Research Organisation GmbH - Berlin, Germany
- Centrum Medyczne "Medis" - Bydgoszcz, Poland
- UZ Leuven Gasthuisberg - Leuven, Belgium
- Royal Liverpool University Hospital - Liverpool, United Kingdom
- Amicare Sp. z o.o. S.K. - Lodz, Poland
- University College London Hospitals - London, United Kingdom
- Royal Victoria Infirmary - Newcastle upon Tyne, United Kingdom
- Allmedica Badania Kliniczne Sp z o.o. Sp K. - Nowy Targ, Poland
- NZOZ Eskulap Pabianice - Pabianice, Poland
- SOLUMED Centrum Medyczne - Późna, Poland
- AZ Delta (Campus Rumbeke) - Roeselare, Belgium
- Centralny Szpital Kliniczny MSW w Warszawie - Warsaw, Poland
- WIP Warsaw IBD Point Profesor Kierkus - Warsaw, Poland
- PlanetMed sp. z o.o. - Wroc?aw, Poland