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Study of Metronidazole Delayed-Release Capsules in Comparison With Immediate-Release Tablets (Flagyl) for Safety and Pharmacokinetics

NCT07251127 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-11-26

No results posted yet for this study

Summary

Clostridium difficile Infection (CDI) also referred to as Clostridium difficile associated diarrhea (CDAD) is an infectious disease that is commonly associated with taking broad-spectrum antimicrobials and certain cancer chemotherapy drugs, which unbalance the ecosystem of the colon causing Clostridium difficile to become the predominant part of the microbiota. C. difficile is a Gram-positive anaerobe, non-invasive by remaining in the colon lumen, and produces toxins A and B that cause diseases, ranging from diarrhea, to pseudomembranous colitis, toxic megacolon, colon perforation, sepsis, or death.

CDI is the leading cause of hospital-associated gastrointestinal illness, responsible for \~ 500,000 infections and 29,000 deaths each year in the US. It places a high burden on the health-care system, which costs $4.8 billion annually. Rates of CDI have been increasing since 2000, especially in the elderly with a recent hospitalization or residing in long-term care facility (LTCF). The mortality rate from CDI is 2 to 5% but increases to 10 to 20% among elderly debilitated patients, and is even greater in patients who develop severe colitis or systemic toxicity. More recently, it has become a community pathogen, affecting younger populations who were previously at low risk.

Currently there are limited medicines for treating active CDI, and no new antibiotic approvals in this area after 2011. Fidaxomicin is concerned with its cost and increased burden of resistance; Vancomycin is related to vancomycin-resistant enterococci and saved as the last resort antibiotic; metronidazole as immediate-release tablets (Flagyl) is completely absorbed from the upper GI tract into the systemic blood systems, leaving low and inconsistent drug concentrations at the colon to battle C. difficile. More treatment options are urgently needed.

Gateway Pharma has developed a 505(b)(2) new product, Metronidazole Delayed-Release (DR) Minitablets in Capsule using our patent-protected colon-targeting platform. The goal is to reduce metronidazole blood absorption and increase drug local concentrations at the colon, to achieve 1) improved efficacy and 2) reduced side effects. Our ultimate goal is to restore metronidazole as the first-line medicine for treating CDI.

Conditions

  • Clostridium Difficile Infection (CDI)

Interventions

DRUG

Delayed-release metronidazole

Oral single dose, 500 mg

DRUG

Immediate-release metronidazole

Oral single dose, 500 mg

Sponsors & Collaborators

  • Gateway Pharmaceutical LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-27
Primary Completion
2025-06-06
Completion
2025-06-07
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251127 on ClinicalTrials.gov