Phase 1
N=16
Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
Renal Function Impairment in Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02992236 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Renal Plasma Flow — 541; 663 mL/min — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VAS203 (Drug); Saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- veriNOS operations GmbH
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Plasma Flow |
541; 663 | < 0.0001 sig |
| PRIMARY Glomerular Filtration Rate |
135; 153.5 | — |
| SECONDARY Serum Creatinine Concentration |
0.91; 0.94 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Informed consent in writing available.
- Willing and able to comply with all requirements of the study.
- Male, 18 and 45 years (inclusive).
- Subject has a body weight between 60 kg and 100 kg, extremes included.
- BMI 18 to 27 kg/m2.
- Non-smoker
- Serum creatinine within reference range (≤1.2 mg/dL) and Cockroft-Gault Clearance > 90 ml/min
- 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
- Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgment).
- Serum glutamate oxaloacetate transaminase or glutamate-pyruvate transaminase > 2-times above the upper limit of normal range.
- Subject with Cockcroft-Gault clearance < 90 ml/min.
- Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
- History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
- Office blood pressure at screening higher than 160/100 mmHg, or lower than 95/55 mmHg.
- Office heart rate at screening after at least 5 minutes outside the range of 50- 99 beats per minute (inclusive).
- Concomitant use of OTC medication within 1 week prior to dosing, except use of paracetamol (up to 2 g/day).
- Participation in any other clinical study within 30 days prior to inclusion in this -
Data sourced from ClinicalTrials.gov (NCT02992236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.