NK-1 Antagonism of SLV317 in Humans
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|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)|
|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|
|Study Completion Date :||November 2003|
- effect of SLV317 on substance P-induced venodilation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|