Can the Body's Drug-Clearing enzymes change how clemizole works?
NCT ID NCT07824193
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are running a Phase 1 study to see how clemizole interacts with other medicines in healthy adults aged 18 to 55. In three parts, participants receive clemizole with itraconazole or phenytoin to measure whether those drugs change clemizole levels in the blood. A third part gives clemizole with omeprazole, midazolam, and bupropion to see whether clemizole changes their levels. The goal is to understand these drug interactions before clemizole is tested more widely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- clemizole hydrochloride oral solution, tested alongside itraconazole, phenytoin, omeprazole, midazolam, and bupropion
- What this could lead to
- If the results are clear, doctors could better predict safe doses of clemizole when patients also take common medicines that change how the body processes drugs.
- What could go wrong
- This is an early Phase 1 study in 54 healthy volunteers, so it cannot show whether clemizole works for any condition. Results in healthy people may not match how the drug behaves in patients who are sick or taking other treatments.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
54 people
The number who actually took part.
- Started
-
Jan 2025
- Finished
-
Apr 2025
- Lead sponsor
-
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
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing. * Body mass index ≥18.0 and ≤32.0 kilograms per square meter(kg/m\^2) within 28 days prior to first dosing. Exclusion Criteria: * Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. * History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee. * History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study. Note: Additional inclusion/exclusion criteria may apply, per protocol
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Celerion
Tempe, Arizona, 85283, United States
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