RightFit
RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether afimkibart changes how the body processes other medicines that rely on proteins called CYP enzymes. It is for people with moderately to severely active ulcerative colitis (UC), a disease that causes swelling and sores in the large bowel.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Weigh at least 40 kg (about 88 pounds).
  • Agree to follow the study's birth control rules.
  • Have UC confirmed by medical findings, a camera exam of the bowel, and bowel tissue samples.
  • Have active UC that reaches at least 15 cm (about 6 inches) into the bowel from the anus, confirmed by a camera exam.
  • Have moderately to severely active UC: a modified Mayo score of 5–9, including a camera-exam score of 2 or 3 confirmed by the study's central reviewers.

Who can't join

  • Have Crohn's disease, another listed type of bowel inflammation, or active diverticular disease (inflamed small pouches in the bowel).
  • Have a fistula (an abnormal tunnel) or abscess (a pocket of pus) in the belly or around the anus.
  • Have an ostomy (a bowel opening made through the belly) or an ileoanal pouch (a pouch made from the small bowel).
  • Have or may have primary sclerosing cholangitis, a disease that scars the tubes that carry bile.
  • Do not have a usable vein for a needle or IV.
  • Had major surgery within 6 weeks before screening, or plan to have major surgery during the study.
  • Had alcohol, drug, or chemical abuse within the year before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

CA

FL