Clinical trial NCT02249117: Pharmacokinetics and Pharmacodynamics of BIWH 3 in Healthy Duffy Positive vs. Duffy Negative Male Volunteers
Official title: Pharmacokinetics and Pharmacodynamics of BIWH 3: a Randomised, Placebo-controlled, Double Blind Dose Escalation Study (0.02, 0.06, 0.2, 0.6, and 2.0 μg/kg Intravenous Over One Hour) in Healthy Duffy Positive vs. Duffy Negative Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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


Eligibility 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

Primary outcomes:
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
timeFrame: up to 14 days after drug administration
measure: Area under the plasma concentration-time curve up to the last quantifiable plasma concentration (AUC0-tz)
timeFrame: up to 14 days after drug administration
measure: maximum BIWH 3 plasma concentration (Cmax)
timeFrame: up to 14 days after drug administration
Secondary outcomes:
measure: Monocyte activation
timeFrame: up to 14 days after drug administration
measure: Platelet cell activation
timeFrame: up to 14 days after drug administration
measure: Endothelial cell activation
timeFrame: up to 14 days after drug administration
measure: Inflammatory response
timeFrame: up to 14 days after drug administration
measure: Activation of coagulation
timeFrame: up to 14 days after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 14 days after drug administration
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: up to 14 days after drug administration
measure: Number of subjects with clinically significant findings in ECG
timeFrame: up to 14 days after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 14 days after drug administration
Other outcomes:
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