Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Function Impairment in Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Infusion (6 hours) of Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Infusion of saline

VAS203

Infusion (6 hours) of VAS203 (10 mg/kg)

Group Type ACTIVE_COMPARATOR

VAS203

Intervention Type DRUG

Infusion of NO-Synthase inhibitor VAS203

Interventions

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VAS203

Infusion of NO-Synthase inhibitor VAS203

Intervention Type DRUG

Saline

Infusion of saline

Intervention Type DRUG

Other Intervention Names

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Ronopterin 0.9% sodium chloride

Eligibility Criteria

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Inclusion Criteria

1. Informed consent in writing available.
2. Willing and able to comply with all requirements of the study.
3. Male, 18 and 45 years (inclusive).
4. Subject has a body weight between 60 kg and 100 kg, extremes included.
5. BMI 18 to 27 kg/m2.
6. Non-smoker
7. Serum creatinine within reference range (≤1.2 mg/dL) and Cockroft-Gault Clearance \> 90 ml/min
8. Good general health as judged by the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure and pulse rate) and clinical laboratory parameters (clinical chemistry, hematology, and urinalysis)

Exclusion Criteria

1. Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgment).
2. Serum glutamate oxaloacetate transaminase or glutamate-pyruvate transaminase \> 2-times above the upper limit of normal range.
3. Subject with Cockcroft-Gault clearance \< 90 ml/min.
4. Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
5. History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
6. Office blood pressure at screening higher than 160/100 mmHg, or lower than 95/55 mmHg.
7. Office heart rate at screening after at least 5 minutes outside the range of 50- 99 beats per minute (inclusive).
8. Concomitant use of OTC medication within 1 week prior to dosing, except use of paracetamol (up to 2 g/day).
9. Participation in any other clinical study within 30 days prior to inclusion in this -

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes