The Clostridioides Difficile Trial of REC-3964

Last updated: November 4, 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 REC-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

Study was terminated due to sponsor decision. This decision was not related to safety concerns.

Connect with a study center

  • GANJ - Toms River - Ocean Family Gastroenterology

    Toms River 4504476, New Jersey 5101760 08755
    United States

    Site Not Available

  • Southern Star Research Institute, LLC

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

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