Status:
NOT_YET_RECRUITING
Skin Inflammation and PK of Azithromycin
Lead Sponsor:
Medical University of Vienna
Conditions:
Skin Infection
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This study will investigate the tissue distribution of azithromycin in healthy, artificially inflamed and actually infected tissue of humans.
Detailed Description
This single-center, prospective, open-label, adaptive, pharmacokinetic study will comprise three parts: Part 0a-c, Part A, and Part B. Objectives: This study primarily aims to characterize and establ...
Eligibility Criteria
Inclusion
- • 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06170983
Start Date
January 1 2024
End Date
July 1 2026
Last Update
December 14 2023
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