NK-1 Antagonism of SLV317 in Humans

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00160862
First received: September 8, 2005
Last updated: September 9, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: SLV317
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • effect of SLV317 on substance P-induced venodilation

Estimated Enrollment: 18
Study Start Date: May 2003
Estimated Study Completion Date: November 2003
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male non-smoking volunteers, age: 18-45, with a body mass index (BMI) in the range from 19-26 (kg/m2), inclusive
  • Good health as determined by medical history, physical examination, electrocardiogram, serum/urine biochemistry and haematology
  • A lying blood pressure after resting for 5 minutes between 100 150 mmHg (systolic) and 50-90 mmHg (diastolic)
  • A lying heart rate (ECG) after resting for 5 minutes between 45 and 100 beats/min.
  • Able and willing to give written informed consent

Exclusion Criteria:

  • Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, smoking, arterial hypertension, hyperhomocysteinaemia)
  • Evidence of cardiovascular, gastrointestinal/hepatic, neurologic/psychiatric, respiratory, urogenital, haematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery, or other relevant diseases as revealed by history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constituting a risk factor when taking the study medication
  • A known history of epilepsy or with relatives with epilepsy
  • Use of any drugs (prescribed and non-prescribed) within the last 2 weeks with the exception of paracetamol up to 48 hours before start of the study
  • Any acute or chronic illness
  • Participation in clinical trial or blood donation within 2 months before the study
  • Drug and/or alcohol abuse or use of alcoholic beverages within 48 hours prior to the study or with a positive drug or alcohol test
  • Use of tobacco or nicotine in any form or with a cotinine urinary level above 500 ng/ml
  • Carriers of the Hepatitis B surface antigen (HBsAg) or carriers of the Hepatitis C or HIV virus
  • A body temperature above 37.5 °C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160862

Locations
Germany
Dept. of Internal Medicine VI, University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Walter E Haefeli, MD Heidelberg University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00160862     History of Changes
Other Study ID Numbers: K071
Study First Received: September 8, 2005
Last Updated: September 9, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 15, 2014