New ulcerative colitis drug put through drug interaction test
NCT ID NCT07665723
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times
Summary
This early-phase study is testing whether afimkibart, an experimental drug for ulcerative colitis, changes how the body processes common medications like caffeine, warfarin, and omeprazole. About 25 people with moderate to severe active ulcerative colitis will receive afimkibart along with a cocktail of these drugs to measure any interactions. The goal is to gather safety and drug-processing data, not to treat the disease directly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Afimkibart (also known as RO7790121, PF-06480605, RVT-3101)
- What this could lead to
- If successful, this study will show whether afimkibart changes how the body processes other drugs, helping doctors prescribe safer combinations for ulcerative colitis.
- What could go wrong
- This is a very early, small study (25 people) focused on drug interactions, not on treating the disease itself. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
18 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AZ Delta (Campus Rumbeke)
RECRUITINGRoeselare, 8800, Belgium
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Allied Biomedical Research Institute, Inc
RECRUITINGMiami, Florida, 33155, United States
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Allmedica Badania Kliniczne Sp z o.o. Sp K.
RECRUITINGNowy Targ, 34-400, Poland
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Amicare Sp. z o.o. S.K.
RECRUITINGLodz, 91-495, Poland
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Centralny Szpital Kliniczny MSW w Warszawie
RECRUITINGWarsaw, 02-507, Poland
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Centrum Medyczne "Medis"
RECRUITINGBydgoszcz, 85-229, Poland
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Charite Research Organisation GmbH
RECRUITINGBerlin, 10117, Germany
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Erick H. Alayo Medical Corporation - Gastro SB Clinic
RECRUITINGChula Vista, California, 91910, United States
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Gastro Health Research
RECRUITINGMiami, Florida, 33176-2416, United States
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Medrise sp z o.o
RECRUITINGLublin, 20-582, Poland
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NZOZ Eskulap Pabianice
RECRUITINGPabianice, 92-500, Poland
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PlanetMed sp. z o.o.
RECRUITINGWroc?aw, 52-210, Poland
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Royal Liverpool University Hospital
RECRUITINGLiverpool, L7 8XP, United Kingdom
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Royal Victoria Infirmary
RECRUITINGNewcastle upon Tyne, NE1 4LP, United Kingdom
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SOLUMED Centrum Medyczne
RECRUITINGPóźna, 60-529, Poland
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UZ Leuven Gasthuisberg
RECRUITINGLeuven, 3000, Belgium
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University College London Hospitals
RECRUITINGLondon, W1T 7HA, United Kingdom
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WIP Warsaw IBD Point Profesor Kierkus
RECRUITINGWarsaw, 04-501, Poland
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