Status:
COMPLETED
NK-1 Antagonism of SLV317 in Humans
Lead Sponsor:
Heidelberg University
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2003
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00160862
Start Date
May 1 2003
End Date
November 1 2003
Last Update
September 12 2005
Active Locations (1)
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1
Dept. of Internal Medicine VI, University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120