Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160862
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Brief Title:
NK-1 Antagonism of SLV317 in Humans
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 425 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
Pharmacodynamic assessments will be performed up to 425 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None