The Clostridioides Difficile Trial of REC-3964

Last updated: June 9, 2025
Sponsor: Recursion Pharmaceuticals Inc.
Overall Status: Terminated

Phase

2

Condition

N/A

Treatment

REC-3964

Clinical Study ID

NCT06536465
REC-3964-201
  • Ages 18-115
  • All Genders

Study Summary

This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of RE-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides difficile infection (CDI).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Be 18 years of age or older with Clostridioides difficile infection (CDI) diarrheaassociated with a positive stool test for C. difficile toxin[s] prior to thepreceding curative treatment.

  • The CDI episode, severe or otherwise, must have resolved after receiving vancomycinwith a standard duration of treatment. The participant must be randomized within 2days of completing the preceding curative treatment.

  • Have high risk for rCDI (a recurrent CDI episode within the last 6 months, age ≥65years, immunocompromised state, or severe CDI with resolution prior to enrollmentinto the study).

Exclusion

Key Exclusion Criteria:

  • Have an active, symptomatic, chronic diarrheal illness from other causes, such asulcerative colitis or Crohn's disease.

  • Diarrhea that requires on-study treatment with agents that would confound theinterpretation of the study results.

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: REC-3964
Phase: 2
Study Start date:
October 14, 2024
Estimated Completion Date:
May 06, 2025

Study Description

The study was terminated due to business decision and there were no safety concerns.

Connect with a study center

  • Northern Arizona Healthcare - Flagstaff Medical Center

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • Nod MD

    Phoenix, Arizona 85022
    United States

    Site Not Available

  • Lawrence J. Ellison Ambulatory Care Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Emory University Hospital Midtown

    Atlanta, Georgia 30365
    United States

    Site Not Available

  • Snake River Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Washington University School of Medicine - Division of Infectious Diseases

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • GANJ - Toms River - Ocean Family Gastroenterology

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Montefiore Medical Group - Family Care Center (FCC)

    Bronx, New York 10467
    United States

    Site Not Available

  • Frontier Clinical Research

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Southern Star Research Institute, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Utah Medical Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Medical Associates of Central Virginia

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison, Wisconsin 53705
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.