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

June 19, 2026 updated by: Hoffmann-La Roche

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Research Organisation GmbH
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Recruiting
        • Royal Liverpool University Hospital
      • London, United Kingdom, W1T 7HA
        • Recruiting
        • University College London Hospitals
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Recruiting
        • Royal Victoria Infirmary
  • United States
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Erick H. Alayo Medical Corporation - Gastro SB Clinic
    • Florida
      • Miami, Florida, United States, 33176-2416
        • Recruiting
        • Gastro Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afimkibart Treatment and CYP Cocktail Group
Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.
Drug: Afimkibart
Afimkibart will be administered as per the schedule defined in the protocol.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121
Drug: Caffeine
Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Drug: Warfarin
Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Drug: Omeprazole
Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Drug: Dextromethorphan
Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Drug: Midazolam
Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.
Other: Vitamin K
Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
Up to approximately 13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Predose and Peak Serum Concentration of Afimkibart
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA46438
  • 2025-524060-38-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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