HealthyPhase 1NCT02249117
Pharmacokinetics and Pharmacodynamics of BIWH 3 in Healthy Duffy Positive vs. Duffy Negative Male Volunteers
A Phase 1 study testing BIWH 3 in people with Healthy, run by Boehringer Ingelheim.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIWH 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Aug 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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 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
- Being tested
- BIWH 3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIWH 3Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIWH 3 | Experimental | single escalating dose Receives: Drug: BIWH 3 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
Measured: up to 14 days after drug administration
Area under the plasma concentration-time curve up to the last quantifiable plasma concentration (AUC0-tz)
Measured: up to 14 days after drug administration
maximum BIWH 3 plasma concentration (Cmax)
Measured: up to 14 days after drug administration
Secondary outcomes (9)
Monocyte activation
Quantification of leukocyte surface markers by flow cytometry
Measured: up to 14 days after drug administration
Platelet cell activation
Quantification of soluble P-selectin by enzyme immunoassay
Measured: up to 14 days after drug administration
Endothelial cell activation
Quantification of soluble E-selectin by enzyme immunoassay
Measured: up to 14 days after drug administration
Inflammatory response
Quantification of mRNA expression of IL-1 by reverse transcriptase-polymerase chain reaction (RT-PCR)
Measured: up to 14 days after drug administration
Activation of coagulation
Prothrombin fragment levels via an enzyme-immunoassay
Measured: up to 14 days after drug administration
Number of subjects with adverse events
Measured: up to 14 days after drug administration
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate, body temperature
Measured: up to 14 days after drug administration
Number of subjects with clinically significant findings in ECG
Measured: up to 14 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 14 days after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJun 2003
- Primary completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249117
- Sponsor's protocol ID
- 1181.2
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02249117
- Acronym / sponsor ID
- 1181.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Aug 2003 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIWH 3 | Experimental | Drug: BIWH 3single escalating dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIWH 3 | Drug | BIWH 3 |
| Placebo | Drug | Placebo |
Primary outcome
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
Time frame: up to 14 days after drug administration
Area under the plasma concentration-time curve up to the last quantifiable plasma concentration (AUC0-tz)
Time frame: up to 14 days after drug administration
maximum BIWH 3 plasma concentration (Cmax)
Time frame: up to 14 days after drug administration
9 secondary outcomes
Monocyte activation
Time frame: up to 14 days after drug administration
Platelet cell activation
Time frame: up to 14 days after drug administration
Endothelial cell activation
Time frame: up to 14 days after drug administration
Inflammatory response
Time frame: up to 14 days after drug administration
Activation of coagulation
Time frame: up to 14 days after drug administration
Number of subjects with adverse events
Time frame: up to 14 days after drug administration
Number of subjects with clinically significant findings in vital signs
Time frame: up to 14 days after drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 14 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 14 days after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIWH 3 in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞) (time frame: up to 14 days after drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.