New capsule aims to revive old antibiotic for gut infection
NCT ID NCT07251127
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new delayed-release metronidazole capsule designed to release the drug directly in the colon, where C. diff bacteria live. 18 healthy adults will receive a single dose of either the new capsule or the standard tablet to compare how much drug reaches the colon versus the bloodstream. The goal is to improve treatment of C. diff infections while reducing side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metronidazole delayed-release capsules
- What this could lead to
- If successful, this new capsule could deliver more drug to the colon, potentially making metronidazole a more effective and safer first-line treatment for C. diff infections.
- What could go wrong
- This is a very early Phase 1 study in only 18 healthy people, so it cannot prove the drug works for patients. The new capsule may not improve outcomes or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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18 people
The number who actually took part.
- Started
-
May 2025
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects aged between 18 and 45 years (both inclusive). 2. Subjects' weight within normal range according to normal values for Body Mass Index (between 18.5 and 30.0 kg/m2) (both inclusive) with minimum of 45 kg weight. 3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the normal range. 4. Subjects having normal 12-lead electrocardiogram (ECG). 5. Subjects having normal chest X-Ray (PA view), if taken. 6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine). 7. Subjects having negative urine alcohol test / breath alcohol test. 8. Non-smoker. 9. Subjects willing to adhere to the protocol requirements and to provide written informed consent. 10. Subjects having negative urine pregnancy test at screening and negative serum b-hCG pregnancy test on admission day of period 01 (only for female subjects). Exclusion Criteria: 1. Hypersensitivity to Metronidazole, nitroimidazole derivatives or related class of drugs or any of its excipients or heparin. 2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder. 3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01. 4. Presence of alcoholism or drug abuse. 5. History or presence of asthma, urticaria or other significant allergic reactions. 6. Subjects with known history of Cockayne's syndrome 7. History or presence of significant gastric and/or duodenal ulceration. 8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor. 9. History or presence of cancer or basal or squamous cell carcinoma. 10. Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcohol containing products within 48.00 hours prior to admission in period 01. 11. Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01. 12. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C. 13. History or presence of significant easy bruising or bleeding. 14. History or presence of significant recent trauma. 15. Female subjects who are currently breast feeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Veeda Lifesciences
Ahmedabad, Gujarat, India