Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and
pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with
moderate and severe traumatic brain injury. Traumatic brain injury patients (32 males)
receive 15, 20 and 30 mg/kg VAS203, respectively, by continuous infusion in three cohorts
(Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled). End of Study
for all patients will be Day 14; adverse events and concomitant medications will be
documented throughout the study.
Objectives are to assess safety and tolerability of VAS203, to evaluate concentrations of
metabolites of VAS203 in plasma and microdialysate and to assess pharmacodynamic effects of
VAS203 on surrogate parameters. Safety parameter will include vital signs (blood pressure
heart rate, respiration rate, oxygen saturation and blood gases), fluid balance, ECG,
laboratory examinations (clinical chemistry, liver function, haematology/coagulation,
urinalysis, renal parameters) and adverse events. Concentration of VAS203 will be determined
in plasma and microdialysate. Pharmacodynamic parameters will include intracranial pressure
(ICP), biochemical parameters in microdialysate (nitrite/nitrate, arginine, citrulline,
pyruvate, lactate, glucose), Partial Oxygen Pressure in brain parenchyma and Therapy
Intensity Level (TIL).