Azithromycin Oleogel for Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new form of azithromycin, a common antibiotic, to compare its absorption in the body with the standard pill. Researchers are examining two new delivery methods: an oral gel and a rectal gel, known as Azithromycin Oleogel. The goal is to determine if these new forms are safe and as effective as the usual pill. Healthy individuals weighing between 45 and 220 pounds, with no history of issues with azithromycin, might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a medical condition that might affect how azithromycin works in your body, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that azithromycin is a well-known and generally safe antibiotic. Studies have found that when azithromycin is mixed into a gel-like form called an oleogel, it remains stable and safe. The azithromycin oral and rectal oleogels use ingredients considered safe in small amounts.
In studying these oleogel forms, initial safety checks involved healthy volunteers. Participants reported their symptoms, and results suggested that the oleogels were generally well-tolerated, with most people experiencing no significant side effects.
Since the current study is in an early phase, it primarily focuses on how the body absorbs the drug and assesses its safety. This phase is crucial but doesn't yet reveal all possible side effects. However, because azithromycin is already approved for other uses, there is some confidence in its safety.12345Why are researchers excited about this trial's treatments?
The Azithromycin Oleogel treatments are unique because they offer new delivery methods for fighting infections. Unlike standard oral azithromycin tablets, which are swallowed, the oral oleogel provides a gel-like form that could be easier to take for those with swallowing difficulties. Additionally, the rectal oleogel provides an alternative route of administration, potentially benefiting patients who are unable to take medications orally. Researchers are excited about these new options because they could improve patient compliance and make azithromycin accessible to a broader range of patients.
What evidence suggests that this trial's treatments could be effective for infections?
Research has shown that azithromycin, a common antibiotic, is being tested in a new gel form called oleogel. In this trial, participants will receive either an oral oleogel, a rectal oleogel, or a reference azithromycin tablet. Studies have found that when azithromycin is mixed into this gel, it remains stable and continues to fight bacteria effectively. Early tests suggest that the body absorbs azithromycin well from this gel, indicating that oleogel could be an effective new way to deliver the antibiotic.45678
Are You a Good Fit for This Trial?
This trial is for healthy individuals with normal blood, liver, and kidney function. Participants must be willing to use two forms of contraception or practice abstinence during the study. It's not specified who can't join because the exclusion criteria are cut off.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive a single dose of rectal oleogel, oral oleogel, or oral reference tablet under fasting conditions with blood samples collected over 72 hours.
Washout
Participants have a washout period to allow for drug clearance before the next treatment period.
Treatment Period 2
Participants receive a different formulation of azithromycin as per randomization schedule with similar procedures as Treatment Period 1.
Washout
Participants have a washout period to allow for drug clearance before the next treatment period.
Treatment Period 3
Participants receive the final formulation of azithromycin as per randomization schedule with similar procedures as previous treatment periods.
Follow-up
End-of-study evaluation performed after completion of the final PK sample following Treatment Period 3 or up to 7 days thereafter.
What Are the Treatments Tested in This Trial?
Interventions
- Azithromycin Oleogel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Bill and Melinda Gates Foundation
Collaborator