healthy male participants
Conditions
Interventions
Group 1: Everolimus (Certican®) in the form of tablets as an unconditioned stimulus, four 2.5mg tablets per phase on three days at 12-hour intervals.
Group 2: Placebo tablets instead of Everolimus tab
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Only healthy male non-smokers between the ages of 18 and 40 will be included. Each subject will be given a comprehensive medical examination at the Clinic for Infectious Diseases approximately 1 week before the start of the study (anamnesis interview, internal examination, blood test, ECG). A final examination will be carried out one week after participation in the study.
Exclusion criteria
Exclusion criteria: The presence of immunological, endocrine, cardiovascular, haematological and psychiatric diseases leads to exclusion from the study. Further exclusion criteria are an increased BMI (>30), allergies e.g. to substances used during the study (lactose intolerance), liver or kidney diseases, obstructive respiratory diseases, addictions or diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (A) T-cell proliferation, at the beginning and end of each conditioning phase; (B) IL2 and IL10 and IFNgamma concentrations in the cell culture supernatant (PBMCs) at the beginning and end of each conditioning phase; (C) mRNA expression of IL2 and IL10 and IFNgamma at the beginning and end of each conditioning phase; (D) Phosphorylation status of p70s6 kinase (Everolimus activity) | — |
Secondary
| Measure | Time frame |
|---|---|
| (A) cell populations (positive CD3, positive CD4, positive CD8, positive CD19 and positive CD45) per phenotype staining of whole blood, at the beginning and at the end of each conditioning phase; (B) cortisol levels in plasma and saliva, at the beginning and end of each conditioning phase; (C) catecholamines in plasma at the beginning and end of each conditioning phase; (D) psychological parameters (anxiety, well-being, stress) using psychological questionnaires (STAI, MDBF, PSQ), at the beginning and at end of each conditioning phase | — |
Countries
Germany
Contacts
Public ContactAnna Lena Friedel
Institut für Medizinische Psychologie
Outcome results
None listed