Health TrialsbyHealthPanel

Skin Inflammation and PK of Azithromycin

ConditionSkin Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMedical University of Vienna

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• 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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Azithromycin

    Drug

    500 mg once daily for 3 days

  • Biopsy

    Diagnostic test

    Skin punch biopsy

  • Skin inflammation model

    Other intervention

    LPS- or imiquimod induced skin inflammation

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Pilot Cohort for Skin InflammationExperimental treatment 2 interventions
Group B: Azithromycin and Artificial Skin InflammationExperimental treatment 2 interventions
Group C: Azithromycin and Skin InfectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 3
2

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.

Time frame
Day 3
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.

Time frame
Day 3
4

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.

Time frame
Day 3

Secondary outcomes

1

Part 0-A: Safety and tolerability of inflammation models

Data will be aggregated as: * number of participants with treatment-related local adverse events due to the inflammation models * number of participants with treatment-related systemic adverse events due to the inflammation models

Time frame
Day 0-3
2

Part A-B: Safety and tolerability of azithromycin

Data will be presented as: * number of participants with treatment-related systemic adverse events due to azithromycin * mean number of treatment-related systemic adverse events due to azithromycin per subject

Time frame
Day 0-3

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: