Skin Inflammation and PK of Azithromycin

NCT06170983 | Not Yet Recruiting

• 1 other identifier: Pro_AZI_IMQ_LPS
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate the tissue distribution of azithromycin in healthy, artificially inflamed and actually infected tissue of humans.

Conditions

Skin Infection

Outcome Measures

Primary Outcomes (6)

• Part 0: Area under the curve (AUC) of azithromycin in artificially inflamed tissue

  The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

  Day 3

• Part 0: Maximum concentration (Cmax) of azithromycin in artificially inflamed tissue

  The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

  Day 3

• Part A: Area under the curve (AUC) Azithromycin in healthy and inflamed tissue

  The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

  Day 3

• Part A: Maximum concentration (Cmax) Azithromycin in healthy and inflamed tissue

  The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

  Day 3

• Part B: Area under the curve (AUC) of Azithromycin in healthy and infected tissue

  The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

  Day 3

• Part B: Maximum concentration (Cmax) of Azithromycin in healthy and infected tissue

  The pharmacokinetic concentration-time profile in tissue will be assessed by microdialysis. Concentration-time profiles will be plotted. AUC and Cmax will be used as PK parameters.

  Day 3

Secondary Outcomes (2)

• Part 0-A: Safety and tolerability of inflammation models

  Day 0-3

• Part A-B: Safety and tolerability of azithromycin

  Day 0-3

Study Arms (3)

Pilot Cohort for Skin Inflammation

EXPERIMENTAL

Testing skin inflammation

Diagnostic Test: Biopsy; Other: Skin inflammation model

Azithromycin and Artificial Skin Inflammation

EXPERIMENTAL

Investigating tissue PK of Azithromycin in artificially inflamed tissue

Drug: Azithromycin; Other: Skin inflammation model

Azithromycin and Skin Infection

EXPERIMENTAL

Investigating tissue PK of Azithromycin in actually infected tissue

Drug: Azithromycin

Interventions

Azithromycin DRUG

500 mg once daily for 3 days

Azithromycin and Artificial Skin Inflammation; Azithromycin and Skin Infection

Biopsy DIAGNOSTIC_TEST

Skin punch biopsy

Pilot Cohort for Skin Inflammation

Skin inflammation model OTHER

LPS- or imiquimod induced skin inflammation

Azithromycin and Artificial Skin Inflammation; Pilot Cohort for Skin Inflammation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged ≥18 and \<55 years
• BMI ≥18 and ≤30 kg/m2
• Normal (or clinically irrelevant abnormal) findings in medical history and physical examination
• Women with child-bearing potential: use of effective contraception
• Laboratory parameters within the given reference range (or abnormal findings which are irrelevant for study purposes in the Investigator's opinion)

You may not qualify if:

• Known or suspected allergy to lipopolysaccharide, imiquimod, or sticking plasters
• Only Part 0c: Known or suspected allergy to local anesthetics
• History of severe allergic or anaphylactic reactions to any medication • Blood donation within the last 4 weeks before the study
• Treatment with an investigational drug within three weeks before the study
• Smoking of more than 5 cigarettes per day
• Regular use of medication or abuse of alcohol
• Use of any medication within one week before the study
• Symptoms of a clinically relevant illness in the 3 months before the study
• Liver or kidney dysfunction
• Pregnancy
• History of autoimmune diseases (especially psoriasis)
• Other objections to participating in the study in the opinion of the Investigator

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Cellulitis

Interventions

Azithromycin; Biopsy

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 14, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 14, 2023

Record last verified: 2023-12