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

NCT02249117 | Completed Phase 1

• 1 other identifier: 1181.2
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)

  up to 14 days after drug administration

• Area under the plasma concentration-time curve up to the last quantifiable plasma concentration (AUC0-tz)

  up to 14 days after drug administration

• maximum BIWH 3 plasma concentration (Cmax)

  up to 14 days after drug administration

Secondary Outcomes (9)

• Monocyte activation

  up to 14 days after drug administration

• Platelet cell activation

  up to 14 days after drug administration

• Endothelial cell activation

  up to 14 days after drug administration

• Inflammatory response

  up to 14 days after drug administration

• Activation of coagulation

  up to 14 days after drug administration

Study Arms (2)

BIWH 3

EXPERIMENTAL

single escalating dose

Drug: BIWH 3

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIWH 3 DRUG

BIWH 3

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: September 25, 2014
• Study Start: June 1, 2003
• Primary Completion: August 1, 2003
• Last Updated: September 25, 2014

Record last verified: 2014-08