A single center, open-label pilot study in healthy subjects using dermal open flow microperfusion to collect body fluids for bioanalytical matrix validation and to explore the effects of topical product removal on dermal kinetics

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

5 Feb 2025 → 3 Jul 2025

Decision date (initial)

2024-11-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Joanneum Research Ges.m.b.H, HEALTH (FDA grant)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

To assess the impact of different removal times on dermal PK.

Conditions and MedDRA coding

No medical condition is being investigated in this clinical trial.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
2. “Healthy Subjects” according to definition in the FDA draft guidance on BE studies with PK endpoints (Aug. 2021)), i.e. subjects who are non-smoking adults 18 years of age or older without existing medical conditions or required medications other then allowed as per Exclusion Criterium (EC) no. 5. The criteria for “healthy subjects” in the FDA guidance are closely followed due to the fact that study Part A aims to obtain matrices characteristic of the matrices of future BE study populations.
3. BMI within the range 18-30 kg/m2 (inclusive)
4. Males or non-pregnant, non-breast-feeding females using adequate contraceptive methods or abstinence
5. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in this protocol

Exclusion criteria 31

1. Known or suspected hypersensitivity to the study interventions or related products, including but not limited to nitroimidazoles or benzyl alcohol.
2. Positive urine drug screen.
3. Clinically significant abnormal laboratory evaluation results, as deemed by the investigator.
4. Positive results to the test for hepatitis B antigen or hepatitis C antibodies.
5. Positive human immunodeficiency virus (HIV) test.
6. Any abnormalities found during physical examination or vital signs, unless deemed not clinically significant by the investigator.
7. Current Smokers.
8. History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
9. Any reason, which in the opinion of the investigator, would prevent the subject from safely participating in the study.
10. Tattoos or broken and/or damaged skin and/or scarring at the application sites.
11. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or inherited blood disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study interventions; or interfering with the interpretation of data.
12. Presence of any clinically relevant acute or chronic disease, which in the investigator´s opinion might jeopardize subject’s safety, evaluation of results or compliance with the protocol.
13. Recent and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.), as judged by the investigator.
14. Use of any medications other than hormonal contraceptive, hormone replacement therapy within 7 days (or 5 half-life periods, whichever is longer) before dosing of study interventions.
15. Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 30 days before signing of consent in this clinical study.
16. Blood donation within 30 days or significant loss of blood or plasma (more than 550 mL) within 90 days before screening.
17. Clinically significant abnormal 12-lead ECG at screening, as deemed by the investigator.
18. Positive alcohol breath test.
19. Subjects prone to keloid or hypertrophic scar formation or any known wound healing disorder.
20. History of severe allergies to drugs or foods, as well as plaster allergy, or a history of severe anaphylactic reaction.
21. Not willing to avoid excessive sun exposure, steam baths, sauna, swimming, and other strenuous activities for 14 days after Visit 2 to ensure good tissue regeneration
22. Pronounced hairiness on the planned application sites that may negatively affect BE testing.
23. Not willing to refrain from shaving the planned application sites or using skin care products on the planned application sites for at least 5 days before Visit 2.
24. Presence of needle phobia.
25. Increased risk of thrombosis e.g., personal or first-degree relative(s) history of deep vein thrombosis.
26. Intervention Visit Exclusion Criteria: Presence of any medical condition that may confound the results of the study or pose an unacceptable risk to the subject, as judged by the investigator.
27. Intervention Visit Exclusion Criteria: Consumption of alcohol within 24 hours before the study, or positive result of alcohol breath test.
28. Intervention Visit Exclusion Criteria: Positive result of urine drug test.
29. Intervention Visit Exclusion Criteria: Any use of metronidazole products within 7 days before the study.
30. Intervention Visit Exclusion Criteria: Shaving and any use of cosmetic products within 5 days before the study on the thighs.
31. Intervention Visit Exclusion Criteria: Positive pregnancy test.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Dermal PK profile (drug concentration over time) for defined removal times
2. Dermal PK parameter (e.g. AUC, Cmax, tmax) for defined removal times
3. Serum PK profile (drug concentration over time)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Neue Stiftingtalstrasse 6

City

Graz

Postcode

8010

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

Dr. Eva Svehlikova

Public contact point

Organisation

Medical University Of Graz

Contact name

Dr. Eva Svehlikova

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications