The Clostridioides Difficile Trial of REC-3964 (ALDER)

Recursion Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Recurrent Clostridioides Difficile Infection

Treatments: Drug: REC-3964

Study type: Interventional

Funder types: Industry

Identifiers

NCT06536465

REC-3964-201

Details and patient eligibility

About

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).

Full description

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

Enrollment: 3 patients

Sex: All

Ages: 18 to 115 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Be 18 years of age or older with Clostridioides difficile infection (CDI) diarrhea associated with a positive stool test for C. difficile toxin[s] prior to the preceding curative treatment.
• The CDI episode, severe or otherwise, must have resolved after receiving vancomycin with a standard duration of treatment. The participant must be randomized within 2 days of completing the preceding curative treatment.
• Have high risk for rCDI (a recurrent CDI episode within the last 6 months, age ≥65 years, immunocompromised state, or severe CDI with resolution prior to enrollment into the study).

Key Exclusion Criteria:

• Have an active, symptomatic, chronic diarrheal illness from other causes, such as ulcerative colitis or Crohn's disease.
• Diarrhea that requires on-study treatment with agents that would confound the interpretation of the study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

REC-3964 High-dose

Experimental group

Description:

Participants will receive 500 mg REC-3964 q12h REC-3964 250 mg capsules

Treatment:

Drug: REC-3964

REC-3964 Low-dose

Experimental group

Description:

Participants will receive 250 mg REC-3964 q12h REC-3964 250 mg capsules

Treatment:

Drug: REC-3964

Observation

No Intervention group

Description:

Participants will undergo watchful waiting