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

Phase 1RecruitingNCT07665723

Hoffmann-La Roche25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Active Ulcerative Colitis

Interventions

AfimkibartDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (18)

Erick H. Alayo Medical Corporation - Gastro SB Clinic

Chula Vista, California, United States

RECRUITING

Allied Biomedical Research Institute, Inc

Miami, Florida, United States

RECRUITING

Gastro Health Research

Miami, Florida, United States

RECRUITING

UZ Leuven Gasthuisberg

Leuven, Belgium

RECRUITING

AZ Delta (Campus Rumbeke)

Roeselare, Belgium

RECRUITING

Charite Research Organisation GmbH

Berlin, Germany

RECRUITING

Centrum Medyczne "Medis"

Bydgoszcz, Poland

RECRUITING

Amicare Sp. z o.o. S.K.

Lodz, Poland

RECRUITING

Medrise sp z o.o

Lublin, Poland

RECRUITING

Allmedica Badania Kliniczne Sp z o.o. Sp K.

Nowy Targ, Poland

RECRUITING

...and 8 more locations

Outcomes

Primary Outcomes

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)