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

NCT05796362 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2022p000272
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Effect; Clinical Infection; Infectious Disease

Keywords

Azithromycin; Oleogel; Clinical trial

Outcome Measures

Primary Outcomes (2)

• Azithromycin bioavailability via pharmacokinetics

  Azithromycin bioavailability of oral and rectal oleogels in healthy volunteers as measured by drug concentrations serum of study participants compared to reference standard bioavailability

  Up to 10 weeks (17 days on study total)

• Initial Azithromycin Oleogel Safety Evaluation

  Initial safety of azithromycin oral and rectal oleogels in healthy volunteers measured by self reported symptoms

  Up to 10 weeks (17 days on study total)

Study Arms (3)

Reference Azithromycin Tablet (Zithromax)

ACTIVE COMPARATOR

250 mg azithromycin (Zithromax) tablet to be taken once orally.

Drug: Azithromycin Oleogel (Oral and Rectal)

Oral Oleogel

EXPERIMENTAL

250 mg azithromycin/ 15 ml oral oleogel (16.67 mg/ml) to be dosed once orally.

Drug: Azithromycin Oleogel (Oral and Rectal)

Rectal Oleogel

EXPERIMENTAL

250 mg azithromycin/ 15 ml rectal oleogel (16.67 mg/ml) to be dosed once rectally.

Drug: Azithromycin Oleogel (Oral and Rectal)

Interventions

Azithromycin Oleogel (Oral and Rectal) DRUG

Exploratory study of a novel "oleogel" dosage form of Azithromycin (Zithromax)

Oral Oleogel; Rectal Oleogel; Reference Azithromycin Tablet (Zithromax)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Administration, Rectal

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Mucosal; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, balanced, single dose, three-treatment, three-period, crossover bioavailability study of azithromycin oleogel in healthy, adult, human subjects under fasting condition.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: April 3, 2023
• Study Start: August 8, 2024
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)