NK-1 Antagonism of SLV317 in Humans
The primary objective is to determine the effect of a single oral dose of 250 mg SLV 317 on substance P-induced venodilation in the hand vein of healthy male volunteers as compared to placebo.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Diagnostic
|Official Title:||A Randomised, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Effect of a Single Oral Dose of SLV 317 on Substance P-Induced Venodilation in the Hand Vein of Healthy Male Volunteers|
- effect of SLV317 on substance P-induced venodilation
|Study Start Date:||May 2003|
|Estimated Study Completion Date:||November 2003|
This will be a double-blind, placebo-controlled, oral single dose cross-over study. 18 healthy male volunteers will receive 250 mg SLV 317 or placebo in randomised order with a minimum wash-out period of one week between the two administrations.
Pharmacodynamic assessments will be performed up to 4.25 hours post-dose using the dorsal hand vein compliance technique. After obtaining venoconstriction via infusions of phenylephrine, substance P will be co-infused intermittently to induce venodilation. Substance P infusions will be separated by intervals of 45 minutes in order to prevent the well-known occurrence of tolerance.
Venous blood sampling for pharmacokinetic evaluation will be performed up to 24 hours post-dose.
Safety will be assessed by measuring ECG, pulse rate, blood pressure, haematology, blood chemistry, urinalysis, and by monitoring of adverse events.
|Dept. of Internal Medicine VI, University of Heidelberg|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Principal Investigator:||Walter E Haefeli, MD||Heidelberg University|