RECRUITING

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

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Infectious Disease Drug Effect Clinical Infection Azithromycin Oleogel Clinical trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Balanced, Single Dose, Three-treatment, Three-period, Crossover Bioavailability Study of Azithromycin Oleogel in Healthy, Adult, Human Subjects Under Fasting Condition.

Quick Facts

Study Start:2024-08-08

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05796362

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Carlo Giovanni Traverso, MB BChir PhD

CONTACT

617-732-7429

ctraverso@bwh.harvard.edu

Peter Chai, MD MMS

CONTACT

617-732-5640

pchai@bwh.harvard.edu

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08

Study Completion Date2025-10

Study Record Updates

Study Start Date2024-08-08

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Azithromycin
Oleogel
Clinical trial

Additional Relevant MeSH Terms

Infectious Disease
Drug Effect
Clinical Infection