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

NCT07665723 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: GA464382025-524060-38-00
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 7

Brief 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 moderately to severely active ulcerative colitis (UC).

Conditions

Active Ulcerative Colitis

Outcome Measures

Primary Outcomes (8)

• 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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  Up to approximately 13 weeks

Secondary Outcomes (2)

• Percentage of Participants with Adverse Events (AEs)

  Up to approximately 5 years

• Predose and Peak Serum Concentration of Afimkibart

  Up to approximately 5 years

Study Arms (1)

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.

Drug: Afimkibart; Drug: Caffeine; Drug: Warfarin; Drug: Omeprazole; Drug: Dextromethorphan; Drug: Midazolam; Other: Vitamin K

Interventions

Afimkibart DRUG

Afimkibart will be administered as per the schedule defined in the protocol.

Also known as: RO7790121, PF-06480605, RVT-3101

Afimkibart Treatment and CYP Cocktail Group

Caffeine DRUG

Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Afimkibart Treatment and CYP Cocktail Group

Dextromethorphan DRUG

Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Afimkibart Treatment and CYP Cocktail Group

Midazolam DRUG

Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Afimkibart Treatment and CYP Cocktail Group

Vitamin K OTHER

Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol.

Afimkibart Treatment and CYP Cocktail Group

Omeprazole DRUG

Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Afimkibart Treatment and CYP Cocktail Group

Warfarin DRUG

Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol.

Afimkibart Treatment and CYP Cocktail Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of alcohol, drug, or chemical abuse \< 1 year prior to screening

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Erick H. Alayo Medical Corporation - Gastro SB Clinic

Chula Vista, California, 91910, United States

RECRUITING

Allied Biomedical Research Institute, Inc

Miami, Florida, 33155, United States

RECRUITING

Gastro Health Research

Miami, Florida, 33176-2416, United States

RECRUITING

Charite Research Organisation GmbH

Berlin, 10117, Germany

RECRUITING

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

RECRUITING

University College London Hospitals

London, W1T 7HA, United Kingdom

RECRUITING

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

RECRUITING

Related Links

• 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.

MeSH Terms

Interventions

Caffeine; Warfarin; Omeprazole; Dextromethorphan; Midazolam; Vitamin K

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines; Naphthoquinones; Naphthalenes; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phytol; Diterpenes; Terpenes

Central Study Contacts

Reference Study ID Number : GA46438 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 24, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); DE (1); GB (3)