NK-1 Antagonism of SLV317 in Humans
|ClinicalTrials.gov Identifier: NCT00160862|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: SLV317||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||May 2003|
|Estimated Study Completion Date :||November 2003|
- effect of SLV317 on substance P-induced venodilation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160862
|Dept. of Internal Medicine VI, University of Heidelberg|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Principal Investigator:||Walter E Haefeli, MD||Heidelberg University|