Print

Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Afimkibart Treatment and CYP Cocktail Group 		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
    Afimkibart will be administered as per the schedule defined in the protocol.
    Other names:
    • RO7790121
    • PF-06480605
    • RVT-3101
  • 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.

Recruiting Locations

Erick H. Alayo Medical Corporation - Gastro SB Clinic
Chula Vista, California 91910

Gastro Health Research
Miami, Florida 33176-2416

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number : GA46438 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.