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 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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07665723

Enrollment

Registered

2026-06-24

Start date

2026-06-29

Completion date

2030-12-31

Last updated

2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Ulcerative Colitis

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).

Interventions

DRUGAfimkibart

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

DRUGCaffeine

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

DRUGWarfarin

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

DRUGOmeprazole

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

DRUGDextromethorphan

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

DRUGMidazolam

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

OTHERVitamin K

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

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)	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

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

Countries

Belgium, Germany, Poland, United Kingdom, United States

Contacts

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

global-roche-genentech-trials@gene.com888-662-6728 (U.S. Only)

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026