Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of BIWH 3 in Healthy Duffy Positive vs. Duffy Negative Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male volunteers: plasma...
Eligibility Criteria
Inclusion
- Healthy male subjects as determined by results of screening
- Erythrocyte Fy positive and negative individuals because expression of the Duffy (Fy) receptor may influence MCP-1 plasma levels in humans
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age ≥ 18 and ≤ 50 years
- Body mass index: ≥18 kg/m2 and \< 30 kg/m2
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory variables unless the investigator considers an abnormality to be clinically irrelevant
- Normal pharmacodynamic variables as determined at baseline visit
- Normal response to glucose tolerance test
Exclusion
- Any finding in the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Current or history of: gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, autoimmune, hormonal disorders, diseases of the central nervous system (such as epilepsy), psychiatric disorders or cancer
- Symptoms of a clinically relevant illness in the 3 weeks prior to planned administration of study drug
- History of orthostatic hypotension, fainting spells and blackouts
- Chronic or relevant acute infections
- History of allergy / hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Any Electrocardiogram (ECG) value outside the reference range of clinical relevance including, but not limited to QRS interval \> 110 ms or QTcB \> 450 ms
- Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to planned administration of study drug
- Use of any drugs which might influence the results of the trial within 10 days prior to planned administration or during the trial
- Participation in another trial with an investigational drug within 2 months prior to planned administration or during trial
- Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Current or history of drug, alcohol, tobacco or caffeine abuse
- Blood donation within 1 month prior to planned administration or during the trial
- Excessive physical activities within 5 days prior to planned administration of study drug or during the trial
- Seropositivity for hepatitis B antigen (HBs-Ag), hepatitis C (HCV), HIV 1, or HIV 2 antibodies
- Weight over 95 kg
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02249117
Start Date
June 1 2003
Last Update
September 25 2014
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