A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel

Completed · Phase 1

Conditions studied: Infectious Disease, Drug Effect, Clinical Infection

In brief

This is an exploratory study to describe the pharmacokinetics of the azithromycin oral and rectal oleogel in humans compared to the reference oral drug to (Zithromax) assess the impact of the novel formulation on bioavailability. The investigators will perform a randomized, balanced, single dose, three-treatment, three-period, crossover oral bioavailability study under fasted conditions to evaluate the safety and tolerability of azithromycin oleogel and compare the bioavailability of the azithromycin oleogel to the reference drug.

Key facts

Study ID

NCT05796362

Run by

Brigham and Women's Hospital

People needed

18

Starts

2024-08-08

Expected to finish

2025-11-25

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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