Conditions: Renal Function Impairment in Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: yes

Brief summary:
Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on renal function and perfusion in 16 healthy subjects.

Detailed description:
Analysis of the effect of i.v. VAS203 on renal function and perfusion in healthy subjects.

Primary objective:

Possible adverse effect of VAS203 on the Renal Plasma Flow (RPF) and the Glomerular Filtration Rate (GFR) during and after 6 hours of constant-rate iv. infusion of 10 mg/kg VAS203.

Secondary objective:

To analyse the effects of VAS203 on

* filtration fraction
* hemodynamics (afferent and efferent resistance, intraglomerular pressure)
* markers of kidney injury and renal function
* systolic, mean and diastolic brachial blood pressure
* Plasma Pharmacokinetic of VAS203 and its first metabolite.

Arms:
arm 1: Infusion (6 hours) of Saline arm 2: Infusion (6 hours) of VAS203 (10 mg/kg)

Interventions: intervention 1: VAS203 intervention 2: Saline
Intervention descriptions: intervention 1: Infusion of NO-Synthase inhibitor VAS203 intervention 2: Infusion of saline

Protocol document: