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

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.

Start Date01 May 2003

Sponsor / Collaborator

Heidelberg University (EMCL)

100 Clinical Results associated with SLV-317

100 Translational Medicine associated with SLV-317

100 Patents (Medical) associated with SLV-317

Literatures (Medical) associated with SLV-317

01 Apr 2006·British Journal of Clinical PharmacologyQ2 · MEDICINE

Kinetics and dynamics of the peripheral neurokinin‐1 receptor antagonist SLV317 in healthy individuals

Q2 · MEDICINE

Article

Author: Christiane Hesse ; Kristina Unnebrink ; Gerd Mikus ; Walter E Haefeli ; Marianne de Bruijn ; Edu Zondag ; Heike Siedler ; Steffen P Luntz ; Monika Seibert-Grafe ; Michiel de Vries

AimsTo investigate the pharmacokinetics and the pharmacodynamic effects in dorsal hand veins of the neurokinin‐1 receptor antagonist SLV317.MethodsIn a randomized, double‐blind, placebo‐controlled cross‐over study 19 healthy men received a single oral dose of SLV317 or placebo. Blood samples were collected for analysis of SLV317 plasma concentrations and the inhibition of the venodilator response to substance P was evaluated using the hand vein compliance method.ResultsAdministration of 250 mg SLV317 as an oral solution was well tolerated and resulted in mean peak plasma concentrations (± SEM) of 77 ± 9 ng ml−1 within 47 ± 3 min; the mean half‐life was 9.9 ± 1.6 h. In hand veins preconstricted with phenylephrine, local infusion of substance P resulted in a mean venodilation of 56 ± 8% and 49 ± 6% (P = 0.91) before administration of SLV317 or placebo, respectively. SLV317 caused a substantial inhibition of substance P‐induced venodilation, whereas placebo had no effect (P < 0.001). The maximum antagonizing effect of SLV317 averaged 95 ± 8% and was observed after 1.47 ± 00.24 h. Correspondingly, the mean area under the effect curve after administration of SLV317 [278 ± 67% h−1; 95% confidence interval (CI) 198, 358] was significantly higher compared with placebo (49 ± 12% h−1; 95% CI −24, 122; P < 0.001).ConclusionsThis study demonstrates that the neurokinin‐1 receptor antagonist SLV317 is an orally active and highly effective antagonist of substance P‐induced effects in humans.

100 Deals associated with SLV-317

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Irritable Bowel Syndrome	Phase 1	DE	-	-
Irritable Bowel Syndrome	Phase 1	US	-	-
Irritable Bowel Syndrome	Phase 1	-	Solvay SA	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

SLV-317

Overview

Basic Info

Structure

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation