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New azithromycin gel shows promise in early absorption study

NCT ID NCT05796362

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a new gel version of the antibiotic azithromycin is absorbed by the body compared to the standard pill. Eighteen healthy adults took the drug in different forms (oral gel, rectal gel, and standard pill) on separate days. The goal was to measure drug levels in the blood and check for any immediate 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

Aug 2024

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Normal, healthy, adult subjects, 18 to 45 years of age, weight of 45 to 100 kg, and body mass index (BMI) between 18.5 to 30.0 kg/m2. * Normal hematological, hepatic and renal function as defined by the testing laboratory's normal ranges, and the inclusion of healthy subjects with out-of-range values that fall within a certain range that have no clinical significance for healthy volunteer expansion. * Willing to use two forms of contraceptive measures or abstinence for the entire duration of the trial. Exclusion Criteria: * Participation in an investigational drug or device study within 90 days prior to study drug dosing, i.e., there must be at least 90 days in between the last dose on a prior study and dose administration on this trial. * Use of tobacco products within the past one year. * Concomitant disease or condition, including laboratory abnormality, which may interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study, including, but not limited to coronary heart disease, diabetes, and adrenal-cortical insufficiency, cancer, alcohol dependency or abuse, drug dependency or abuse, or psychiatric disease. * Current or past medical condition that might significantly affect the pharmacokinetics of azithromycin. * Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. * Have history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

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Conditions

The condition(s) this trial relates to.

infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinical infection Drug effect Infectious disease

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.