The Clostridioides Difficile Trial of REC-3964
- Registration Number
- NCT06536465
- Lead Sponsor
- Recursion Pharmaceuticals Inc.
- Brief 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).
- Detailed Description
The study was terminated due to business decision and there were no safety concerns.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REC-3964 High-dose REC-3964 Participants will receive 500 mg REC-3964 q12h REC-3964 250 mg capsules REC-3964 Low-dose REC-3964 Participants will receive 250 mg REC-3964 q12h REC-3964 250 mg capsules
- Primary Outcome Measures
Name Time Method Number of Participants with Survival Without Recurrence or Requirement for Additional CDI Treatment 8 weeks Number of Participants with Related TEAEs Up to 8 weeks Number of Participants with TEAEs Leading to Study Drug Discontinuation Up to 8 weeks Number of Participants with Treatment-emergent Adverse Events (TEAEs) Up to 8 weeks Number of Participants with Serious TEAEs Up to 8 weeks
- Secondary Outcome Measures
Name Time Method Rate of Recurrent Clostridioides Difficile Infection (rCDI) 8 weeks Number of Unformed [Types 5-7 on the Bristol Stool Scale] Bowel Movements Per Day Up to 8 weeks Time to Maximum Plasma Concentration (Tmax) of REC-3964 Pre-dose, 1 hour, 3 hours, and 6 hours post morning dose on the Day 1 and Day 15 Number of Participants with rCDI Associated Hospital Admissions Up to 8 weeks Maximum Observed Plasma Concentration (Cmax) of REC-3964 Pre-dose, 1 hour, 3 hours, and 6 hours post morning dose on Day 1 and Day 15 Trough Plasma Concentration (Ctrough) of REC-3964 Pre-dose on Day 15 Time to Recurrence Up to 8 weeks Number of Participants with Severe rCDI Up to 8 weeks
Trial Locations
- Locations (2)
GANJ - Toms River - Ocean Family Gastroenterology
🇺🇸Toms River, New Jersey, United States
Southern Star Research Institute, LLC
🇺🇸San Antonio, Texas, United States
GANJ - Toms River - Ocean Family Gastroenterology🇺🇸Toms River, New Jersey, United States