Active Ulcerative ColitisPhase 1NCT07665723
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
A Phase 1 study testing Afimkibart, Caffeine and Warfarin in people with Active Ulcerative Colitis, run by Hoffmann-La Roche at 18 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Active Ulcerative Colitis
- What is being tested?
- Afimkibart, Caffeine and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 29 Jun 2026to 31 Dec 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number : GA46438 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
18 sites in 5 countries
Poland9 sites, 9 recruiting
- Recruiting
Centrum Medyczne "Medis"
Bydgoszcz, 85-229
- Recruiting
Amicare Sp. z o.o. S.K.
Lodz, 91-495
- Recruiting
Medrise sp z o.o
Lublin, 20-582
- Recruiting
Allmedica Badania Kliniczne Sp z o.o. Sp K.
Nowy Targ, 34-400
- Recruiting
NZOZ Eskulap Pabianice
Pabianice, 92-500
- Recruiting
SOLUMED Centrum Medyczne
Późna, 60-529
- Recruiting
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507
- Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
- Recruiting
PlanetMed sp. z o.o.
Wroc?aw, 52-210
United States3 sites, 3 recruiting
- Recruiting
Erick H. Alayo Medical Corporation - Gastro SB Clinic
Chula Vista, California, 91910
- Recruiting
Allied Biomedical Research Institute, Inc
Miami, Florida, 33155
- Recruiting
Gastro Health Research
Miami, Florida, 33176-2416
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal Liverpool University Hospital
Liverpool, L7 8XP
- Recruiting
University College London Hospitals
London, W1T 7HA
- Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Belgium2 sites, 2 recruiting
- Recruiting
UZ Leuven Gasthuisberg
Leuven, 3000
- Recruiting
AZ Delta (Campus Rumbeke)
Roeselare, 8800
Germany1 site, 1 recruiting
- Recruiting
Charite Research Organisation GmbH
Berlin, 10117
About this study
Official title: A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates After Treatment With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis
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).
- Conditions
- Active Ulcerative Colitis
- Being tested
- Afimkibart, Caffeine, Warfarin, Omeprazole, Dextromethorphan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimkibartDrug
Also called RO7790121, PF-06480605, RVT-3101
Afimkibart will be administered as per the schedule defined in the protocol.
CaffeineDrug
Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
WarfarinDrug
Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
OmeprazoleDrug
Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
DextromethorphanDrug
Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
MidazolamDrug
Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Vitamin KOther
Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Afimkibart Treatment and CYP Cocktail Group | Experimental | Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase. Receives: Drug: Afimkibart; Drug: Caffeine; Drug: Warfarin; Drug: Omeprazole; Drug: Dextromethorphan; Drug: Midazolam; Other: Vitamin K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t [AUC last]) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Measured: Up to approximately 13 weeks
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Measured: Up to approximately 13 weeks
Maximum Plasma Concentration (Cmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Measured: Up to approximately 13 weeks
Time to Maximum Concentration (Tmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Measured: Up to approximately 13 weeks
Elimination Half-life (T1/2) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine)
Measured: Up to approximately 13 weeks
Metabolite-to-parent Area Under the Curve From Time 0 (AUC0-t) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine)
Measured: Up to approximately 13 weeks
Metabolite-to-parent Area Under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine)
Measured: Up to approximately 13 weeks
Metabolite-to-parent Concentration of CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine)
Measured: Up to approximately 13 weeks
Secondary outcomes (2)
Percentage of Participants with Adverse Events (AEs)
Measured: Up to approximately 5 years
Predose and Peak Serum Concentration of Afimkibart
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start29 Jun 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665723
- Sponsor's protocol ID
- GA46438
- Other IDs
- 2025-524060-38-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No