Pharmacokinetics and Pharmacodynamics of BIWH 3 in Healthy Duffy Positive vs. Duffy Negative Male Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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 levels of monocyte chemotactic protein-1 (MCP-1) and markers of leukocyte, coagulation, platelet and endothelial activation will be quantified; To examine the safety of BIWH 3 in this setting

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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