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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: BIWH 3

Study type

Interventional

Funder types

Industry

Identifiers

NCT02249117

1181.2

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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