HealthyPhase 1NCT02259881
Effect of BIBT 986 Followed by BIBT 986 Given as IV Infusion on Tissue Factor Triggered Coagulation in Healthy Male Volunteers
A Phase 1 study testing Low dose of BIBT 986 CL, per i.v. infusion, Medium dose of BIBT 986 CL, per i.v. infusion and High dose of BIBT 986 CL, per i.v. infusion in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters of coagulation, platelet activation and inflammation in a model of tissue factor triggered activation of the coagulation system; to examine the safety of BIBT 986 in this setting Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low dose of BIBT 986 CL, per i.v. infusion, Medium dose of BIBT 986 CL, per i.v. infusion and High dose of BIBT 986 CL, per i.v. infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to May 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects as determined by the screening procedure
- Signed written informed consent form in accordance with good clinical practice (GCP) and local legislation was available
- Age ≥ 18 and ≤ 40 years
- Body mass index: BMI ≥ 18 and ≤ 29.9 kg/m2
- Normal findings in medical history and physical examination unless the investigator considered an abnormality to be clinically irrelevant
- Normal laboratory parameters unless the investigator considered an abnormality to be clinically irrelevant
Who cannot join
- Any finding in the medical examination (including blood pressure, pulse rate, ECG, and laboratory parameters) deviating from normal and of clinical relevance
- History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, autoimmune, hormonal disorders, diseases of the central nervous system (such as epilepsy), or psychiatric disorders
- Symptoms of a clinically relevant illness in the 3 weeks before the first trial day
- History of orthostatic hypotension, fainting spells, and blackouts
- Chronic or relevant acute infections
- History of allergy / hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
Show all 25Show fewer
- History of
- any bleeding disorder including prolonged or habitual bleeding
- any familial bleeding disorder
- other haematological disease
- cerebral bleeding (e.g. after a car accident)
- commotio cerebri
- Hereditary deficiency of protein C or S, or a mutation of factor V (Leiden), or any other known abnormality affecting coagulation, fibrinolysis, or platelet function
- Platelet count < 150000/μL
- Any ECG value outside of the reference range of clinical relevance (QRS interval > 110 ms or QTcB (QT interval Bazett correction) > 450 ms will be an obligatory exclusion criterion)
- Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 2 months prior to administration or during trial
- Participation in an LPS trial within the last six weeks
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Concurrent or history of drug, alcohol, tobacco or coffee / tea / cola abuse
- Blood donation within 1 month prior to administration or during the trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Seropositivity for hepatitis B surface antigen (HBs-Ag), hepatitis C virus (HCV), HIV 1, or HIV 2 antibodies
- Weight over 95 kg
About this study
Official title: Investigation of the Effect of 0.9, 2.25 or 4.5 mg of BIBT 986 Over 1 Hour, Followed by 0.2, 0.5 or 1.0 mg/Hour of BIBT 986 for 7 Hours Given as IV Infusion on Tissue Factor Triggered Coagulation in a Randomised, Placebo Controlled, Dose Escalation Design in Healthy Male Volunteers
To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters of coagulation, platelet activation and inflammation in a model of tissue factor triggered activation of the coagulation system; to examine the safety of BIBT 986 in this setting
- Conditions
- Healthy
- Being tested
- Low dose of BIBT 986 CL, per i.v. infusion, Medium dose of BIBT 986 CL, per i.v. infusion, High dose of BIBT 986 CL, per i.v. infusion, Placebo, Lipopolysaccharide (LPS), single i.v. bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of BIBT 986 CL, per i.v. infusionDrug
Medium dose of BIBT 986 CL, per i.v. infusionDrug
High dose of BIBT 986 CL, per i.v. infusionDrug
PlaceboDrug
Lipopolysaccharide (LPS), single i.v. bolusDrug
Endotoxin derived from E. coli bacteria, used for activation of coagulation
| Study group | Role | What they receive |
|---|---|---|
| Low dose of BIBT 986 CL | Experimental | Not described Receives: Drug: Low dose of BIBT 986 CL, per i.v. infusion; Drug: Lipopolysaccharide (LPS), single i.v. bolus |
| Medium dose of BIBT 986 CL | Experimental | Not described Receives: Drug: Medium dose of BIBT 986 CL, per i.v. infusion; Drug: Lipopolysaccharide (LPS), single i.v. bolus |
| High dose of BIBT 986 CL | Experimental | Not described Receives: Drug: High dose of BIBT 986 CL, per i.v. infusion; Drug: Lipopolysaccharide (LPS), single i.v. bolus |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Lipopolysaccharide (LPS), single i.v. bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activated partial thromboplastin time (aPTT)
Measured: up to 48 hours after start of treatment
Change in international normalized ratio (INR)
Measured: up to 48 hours after start of treatment
Change in thrombin time (TT)
Measured: up to 48 hours after start of treatment
Change in ecarin clotting time (ECT)
Measured: up to 48 hours after start of treatment
Change in prothrombin fragment (F1+2)
Measured: up to 48 hours after start of treatment
Change in D-dimer
Measured: up to 48 hours after start of treatment
Change in thrombin anti-thrombin complexes (TAT)
Measured: up to 48 hours after start of treatment
Change in protein C activity
Measured: up to 48 hours after start of treatment
Change in antithrombin
Measured: up to 48 hours after start of treatment
Change in thrombomodulin
Measured: up to 48 hours after start of treatment
Change in tissue factor messenger RNA (mRNA)
Measured: up to 48 hours after start of treatment
Change in platelet count
Measured: up to 48 hours after start of treatment
Change in plasmin antiplasmin complexes (PAP)
Measured: Pre-dose, up to day 14 after start of treatment
Change in soluble P-selectin
Measured: up to 48 hours after start of treatment
Change in tumor necrosis factor alpha (TNF alpha)
Measured: up to 48 hours after start of treatment
Change in interleukin-6 (IL-6)
Measured: up to 48 hours after start of treatment
Change in primary haemostasis measured by closure times
Measured: up to 48 hours after start of treatment
Number of subjects with clinically relevant changes in vital signs
blood pressure, pulse rate, body temperature
Measured: up to 14 days after start of treatment
Number of subjects with clinically relevant changes in laboratory parameters
Measured: up to 14 days after start of treatment
Number of subjects with adverse events
Measured: up to 14 days after start of treatment
Number of subjects with clinically relevant changes in ECG
Measured: up to 14 days after start of treatment
Change in thrombus precursor protein
Measured: up to 48 hours after start of treatment
Change in soluble E-selectin
Measured: up to 48 hours after start of treatment
Secondary outcomes (6)
Area under the plasma concentration-time curve (AUC)
Measured: up to 48 hours after start of treatment
Maximum concentration in plasma at the end of the infusion (Cgh)
Measured: up to 48 hours after start of treatment
Apparent terminal half-life of BIBT 986 in plasma (t1/2)
Measured: up to 48 hours after start of treatment
Mean residence time of BIBT 986 in the body after intravenous bolus administration (MRT)
Measured: up to 48 hours after start of treatment
Volume of distribution of BIBT 986 in plasma at steady state (Vss)
Measured: up to 48 hours after start of treatment
Apparent volume of distribution of BIBT 986 during the terminal phase after intravenous infusion (Vz)
Measured: up to 48 hours after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startDec 2002
- Primary completionMay 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
- 64 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
- NCT02259881
- Sponsor's protocol ID
- 1192.11
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of 0.9, 2.25 or 4.5 mg of BIBT 986 Over 1 Hour, Followed by 0.2, 0.5 or 1.0 mg/Hour of BIBT 986 for 7 Hours Given as IV Infusion on Tissue Factor Triggered Coagulation in a Randomised, Placebo Controlled, Dose Escalation Design in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02259881
- Acronym / sponsor ID
- 1192.11
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- May 2003 (actual)
- First posted
- 9 Oct 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.
To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters of coagulation, platelet activation and inflammation in a model of tissue factor triggered activation of the coagulation system; to examine the safety of BIBT 986 in this setting
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose of BIBT 986 CL | Experimental | Drug: Low dose of BIBT 986 CL, per i.v. infusion, Drug: Lipopolysaccharide (LPS), single i.v. bolus |
| Medium dose of BIBT 986 CL | Experimental | Drug: Medium dose of BIBT 986 CL, per i.v. infusion, Drug: Lipopolysaccharide (LPS), single i.v. bolus |
| High dose of BIBT 986 CL | Experimental | Drug: High dose of BIBT 986 CL, per i.v. infusion, Drug: Lipopolysaccharide (LPS), single i.v. bolus |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Lipopolysaccharide (LPS), single i.v. bolus |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male subjects as determined by the screening procedure
- Signed written informed consent form in accordance with good clinical practice (GCP) and local legislation was available
- Age ≥ 18 and ≤ 40 years
- Body mass index: BMI ≥ 18 and ≤ 29.9 kg/m2
- Normal findings in medical history and physical examination unless the investigator considered an abnormality to be clinically irrelevant
Key exclusion criteria (25 listed)
- Any finding in the medical examination (including blood pressure, pulse rate, ECG, and laboratory parameters) deviating from normal and of clinical relevance
- History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, autoimmune, hormonal disorders, diseases of the central nervous system (such as epilepsy), or psychiatric disorders
- Symptoms of a clinically relevant illness in the 3 weeks before the first trial day
- 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 |
|---|---|---|
| Low dose of BIBT 986 CL, per i.v. infusion | Drug | Low dose of BIBT 986 CL |
| Medium dose of BIBT 986 CL, per i.v. infusion | Drug | Medium dose of BIBT 986 CL |
| High dose of BIBT 986 CL, per i.v. infusion | Drug | High dose of BIBT 986 CL |
| Placebo | Drug | Placebo |
| Lipopolysaccharide (LPS), single i.v. bolusEndotoxin derived from E. coli bacteria, used for activation of coagulation | Drug | High dose of BIBT 986 CL, Low dose of BIBT 986 CL, Medium dose of BIBT 986 CL, Placebo |
Primary outcome
Change in activated partial thromboplastin time (aPTT)
Time frame: up to 48 hours after start of treatment
Change in international normalized ratio (INR)
Time frame: up to 48 hours after start of treatment
Change in thrombin time (TT)
Time frame: up to 48 hours after start of treatment
Change in ecarin clotting time (ECT)
Time frame: up to 48 hours after start of treatment
Change in prothrombin fragment (F1+2)
Time frame: up to 48 hours after start of treatment
Change in D-dimer
Time frame: up to 48 hours after start of treatment
Change in thrombin anti-thrombin complexes (TAT)
Time frame: up to 48 hours after start of treatment
Change in protein C activity
Time frame: up to 48 hours after start of treatment
Change in antithrombin
Time frame: up to 48 hours after start of treatment
Change in thrombomodulin
Time frame: up to 48 hours after start of treatment
Change in tissue factor messenger RNA (mRNA)
Time frame: up to 48 hours after start of treatment
Change in platelet count
Time frame: up to 48 hours after start of treatment
Change in plasmin antiplasmin complexes (PAP)
Time frame: Pre-dose, up to day 14 after start of treatment
Change in soluble P-selectin
Time frame: up to 48 hours after start of treatment
Change in tumor necrosis factor alpha (TNF alpha)
Time frame: up to 48 hours after start of treatment
Change in interleukin-6 (IL-6)
Time frame: up to 48 hours after start of treatment
Change in primary haemostasis measured by closure times
Time frame: up to 48 hours after start of treatment
Number of subjects with clinically relevant changes in vital signs
Time frame: up to 14 days after start of treatment
blood pressure, pulse rate, body temperature
Number of subjects with clinically relevant changes in laboratory parameters
Time frame: up to 14 days after start of treatment
Number of subjects with adverse events
Time frame: up to 14 days after start of treatment
Number of subjects with clinically relevant changes in ECG
Time frame: up to 14 days after start of treatment
Change in thrombus precursor protein
Time frame: up to 48 hours after start of treatment
Change in soluble E-selectin
Time frame: up to 48 hours after start of treatment
6 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: up to 48 hours after start of treatment
Maximum concentration in plasma at the end of the infusion (Cgh)
Time frame: up to 48 hours after start of treatment
Apparent terminal half-life of BIBT 986 in plasma (t1/2)
Time frame: up to 48 hours after start of treatment
Mean residence time of BIBT 986 in the body after intravenous bolus administration (MRT)
Time frame: up to 48 hours after start of treatment
Volume of distribution of BIBT 986 in plasma at steady state (Vss)
Time frame: up to 48 hours after start of treatment
Apparent volume of distribution of BIBT 986 during the terminal phase after intravenous infusion (Vz)
Time frame: up to 48 hours after start of treatment
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 9 Oct 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 Low dose of BIBT 986 CL, per i.v. infusion, Medium dose of BIBT 986 CL, per i.v. infusion and High dose of BIBT 986 CL, per i.v. infusion 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 6 inclusion and 25 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 9 Oct 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?
Change in activated partial thromboplastin time (aPTT) (time frame: up to 48 hours after start of treatment). The study lists 23 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 9 Oct 2014.