RAS Peptide Profile in Healthy Volunteers Clinical Trial
Official title:
Single-center, Randomized, Open-label, 3-way Crossover Study to Characterize the RAS-peptide-profile After Single and Repeated Oral Administration of Different RAS-inhibitors in Healthy Male Subjects
The primary objective is the characterization of the RAS peptide profiles after single and
repeated oral administration of a renin inhibitor, an ACE inhibitor and an angiotensin
receptor blocker in healthy volunteers.
Secondary objectives are the correlation of RAS peptide profiles with pharmacokinetic
profiles of the different RAS inhibitors and with pharmacodynamic parameters such as blood
pressure and heart rate. Output of the classic RAS system will be assessed using aldosterone
concentrations. Fluid and sodium intake will be monitored using sodium concentration and
total volume in 24h urine.
The results of a pilot study have shown that single doses of different RAS inhibitors produce characteristic changes of the RAS peptide profiles. In a first step this finding needs to be verified in a larger number of healthy subjects. Since it is unknown, whether the changes that were observed within hours after a single inhibitor dose are stable over time, the profiles also need to be investigated under steady-state conditions of the different inhibitors. Comparison of RAS peptide profiles after single dose and under steady-state conditions will also allow to detect whether the peptide profiles are altered by compensatory mechanisms. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label