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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07665723
- Acronym / sponsor ID
- GA46438
- Conditions
- Active Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afimkibart Treatment and CYP Cocktail Group | Experimental | Drug: Afimkibart, Drug: Caffeine, Drug: Warfarin, Drug: Omeprazole, Drug: Dextromethorphan, Drug: Midazolam, Other: Vitamin KParticipants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body weight >= 40kg
- Agreement to adhere to the contraceptive requirements
- 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
Key exclusion criteria (8 listed)
- 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
- Lack of peripheral venous access
- Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfimkibartAlso: RO7790121, PF-06480605, RVT-3101Afimkibart will be administered as per the schedule defined in the protocol. | Drug | Afimkibart Treatment and CYP Cocktail Group |
| CaffeineCaffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. | Drug | Afimkibart Treatment and CYP Cocktail Group |
| WarfarinWarfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. | Drug | Afimkibart Treatment and CYP Cocktail Group |
| OmeprazoleOmeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. | Drug | Afimkibart Treatment and CYP Cocktail Group |
| DextromethorphanDextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. | Drug | Afimkibart Treatment and CYP Cocktail Group |
| MidazolamMidazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. | Drug | Afimkibart Treatment and CYP Cocktail Group |
| Vitamin KVitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol. | Other | Afimkibart Treatment and CYP Cocktail Group |
Primary outcome
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to approximately 13 weeks
2 secondary outcomes
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 5 years
Predose and Peak Serum Concentration of Afimkibart
Time frame: Up to approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take 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
Clinical Trials study director
Hoffmann-La Roche
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Poland, United States, United Kingdom, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 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), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to approximately 13 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.