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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-08-20

No results posted yet for this study

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

Interventions

DRUG

Afimkibart

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

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-29
Primary Completion
2027-07-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07665723 on ClinicalTrials.gov