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RECRUITING
NCT07665723
PHASE1

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-06-30

Completion Date

2030-12-31

Last Updated

2026-06-24

Healthy Volunteers

No

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.

Locations (6)

Erick H. Alayo Medical Corporation - Gastro SB Clinic

Chula Vista, California, United States

Gastro Health Research

Miami, Florida, United States

Charite Research Organisation GmbH

Berlin, Germany

Royal Liverpool University Hospital

Liverpool, United Kingdom

University College London Hospitals

London, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom