Physiological study
Conditions
Interventions
Group 1: Single dose of a stable labelled 33-mer oligopeptide with 24 h obeservation period including blood and urine samples. n =3 in the first dose cohort.
The following dose cohorts (also n = 3 ea
Sponsors
Universitätsmedizin Greifswald
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: - understands the study purpose and design - contractually capable and provides signed informed consent form - healthy condition or mild and/or well treated forms of allergies, asthma, hypertension, and orthopedic diseases
Exclusion criteria
Exclusion criteria: a. BMI > 35 kg/m2 and 2x ULN) g. reduced renal function (eGFR MDRD 2 drugs taken during the screening and study visits period l. psychiatric disease or drug dependency m. use of recreational drugs more than twice a week n. poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the occurrence of labelled dipeptides and labelled amino acids in blood and urine samples. We are testing two hypotheses: 1.labelled 33-mer + AMY01 significant amounts of dipeptides and amino acids are detectable 2.labelled 33-mer alone dipeptides and amino acids are detectable in lower amounts if at all | — |
Secondary
| Measure | Time frame |
|---|---|
| - AUC0-10h for each labelled dipeptide and amino acid - Tmax of each labelled dipeptide and amino acid - Cmax of each labelled dipeptide and amino acid - renal clearance of each labelled dipeptide and amino acid | — |
Countries
Germany
Contacts
Public ContactStefan Engeli
Universitätsmedizin Greifswald
Outcome results
None listed