NK-1 Antagonism of SLV317 in Humans

NCT00160862 | Completed Phase 1

• 1 other identifier: K071
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• effect of SLV317 on substance P-induced venodilation

Interventions

SLV317 DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Dept. of Internal Medicine VI, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Interventions

SLV317

Study Officials

• Walter E Haefeli, MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: May 1, 2003
• Study Completion: November 1, 2003
• Last Updated: September 12, 2005

Record last verified: 2005-09

Locations

DE (1)