HealthyPhase 1NCT02254083
Tolerability and Pharmacokinetics/-Dynamics of BIBT 986 BS in Healthy Male Subjects
A Phase 1 study testing BIBT 986 BS - low and BIBT 986 BS - high in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg) BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood coagulation parameters Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBT 986 BS - low and BIBT 986 BS - high
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >= 18 and <= 55 years
- BMI >= 18.5 and <= 29.9 kg/m2
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells or blackouts
- Abnormal PT, TT, aPTT (must be within the normal range after no more than one repeated test), thrombocytes < 150000/μl (two repeats of the first test)
Show all 22Show fewer
- Evidence of hematuria either macroscopically detectable or microscopic on urinalysis (normal microscopic results after no more than one repeated test)
- Evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta, Central nervous system (CNS) trauma, retinopathy, nephrolithiasis)
- Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of CNS or eye or surgery resulting in large open surfaces) within 14 days before or after drug administration of this clinical trial
- Occult blood in 1 of 3 subsequent faecal samples collected for the pre-study examination
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
- Use of any drugs, within 14 days prior to administration or during the trial
- Participation in another trial with an investigational drug (< 2 months prior to administration or during trial)
- Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation or loss > 400 mL, < 1 month prior to administration or during the trial
- Excessive physical activities < 5 days prior to administration of study drug or during trial
- Clinically relevant laboratory abnormalities
- Veins unsuited for i.v. puncture and administration of prolonged infusions on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)
About this study
Official title: Tolerability and Pharmacokinetics/-Dynamics of 0.5 mg and 1.0 mg (Actual 0.8 mg) of BIBT 986 BS Per Hour Given as IV Infusion Over 32 Hours in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level
Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg) BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood coagulation parameters
- Conditions
- Healthy
- Being tested
- BIBT 986 BS - low, BIBT 986 BS - high, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBT 986 BS - lowDrug
BIBT 986 BS - highDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBT 986 BS - low | Experimental | Not described Receives: Drug: BIBT 986 BS - low |
| BIBT 986 BS - high | Experimental | Not described Receives: Drug: BIBT 986 BS - high |
| 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.
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 48 hours post dose
CT (concentration of the analyte at the end of drug infusion)
Measured: up to 48 hours post dose
Css (steady state concentration of the analyte in plasma following a constant rate infusion)
Measured: up to 48 hours post dose
Tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 48 hours post dose
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)
Measured: up to 48 hours post dose
t1/2 (Terminal half-life of the analyte in plasma after single dose administration)
Measured: up to 48 hours post dose
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after single dose administration)
Measured: up to 48 hours post dose
λz (terminal rate constant of the analyte in plasma)
Measured: up to 48 hours post dose
MRTinf (mean residence time of the analyte in the body after intravenous infusion)
Measured: up to 48 hours post dose
CL (Total clearance of the analyte in plasma following intravascular administration)
Measured: up to 48 hours post dose
Vss (Apparent volume of distribution at steady state following intravascular administration)
Measured: up to 48 hours post dose
Vz (apparent volume of distribution during the terminal phase λz following intravascular administration)
Measured: up to 48 hours post dose
Amount of parent drug eliminated in urine (Ae)
Measured: up to 48 hours post dose
Change in activated partial thromboplastin time (aPTT)
Measured: up to 48 hours post dose
Change in prothrombin time (PT)
Measured: up to 48 hours post dose
Change in ecarin clotting time (ECT)
Measured: up to 48 hours post dose
Change in thrombin time (TT)
Measured: up to 48 hours post dose
Number of subjects with adverse events
Measured: up to 4 days
Number of subjects with clinically significant changes in vital signs
Pulse rate, systolic \& diastolic blood pressure
Measured: up to 4 days
Change in International Normalised Ratio (INR)
Measured: up to 48 hours post dose
Fraction of administered drug excreted unchanged in urine (fe)
Measured: up to 48 hours post dose
CLR (renal clearance of the analyte in plasma following intravascular administration)
Measured: up to 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startFeb 2003
- 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
- 16 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
- NCT02254083
- Sponsor's protocol ID
- 1192.2
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Pharmacokinetics/-Dynamics of 0.5 mg and 1.0 mg (Actual 0.8 mg) of BIBT 986 BS Per Hour Given as IV Infusion Over 32 Hours in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level
- ClinicalTrials.gov ID
- NCT02254083
- Acronym / sponsor ID
- 1192.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- May 2003 (actual)
- First posted
- 1 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.
Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg) BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood coagulation parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIBT 986 BS - low | Experimental | Drug: BIBT 986 BS - low |
| BIBT 986 BS - high | Experimental | Drug: BIBT 986 BS - high |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >= 18 and <= 55 years
- BMI >= 18.5 and <= 29.9 kg/m2
Key exclusion criteria (22 listed)
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| BIBT 986 BS - low | Drug | BIBT 986 BS - low |
| BIBT 986 BS - high | Drug | BIBT 986 BS - high |
| Placebo | Drug | Placebo |
Primary outcome
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 48 hours post dose
CT (concentration of the analyte at the end of drug infusion)
Time frame: up to 48 hours post dose
Css (steady state concentration of the analyte in plasma following a constant rate infusion)
Time frame: up to 48 hours post dose
Tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 48 hours post dose
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)
Time frame: up to 48 hours post dose
t1/2 (Terminal half-life of the analyte in plasma after single dose administration)
Time frame: up to 48 hours post dose
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after single dose administration)
Time frame: up to 48 hours post dose
λz (terminal rate constant of the analyte in plasma)
Time frame: up to 48 hours post dose
MRTinf (mean residence time of the analyte in the body after intravenous infusion)
Time frame: up to 48 hours post dose
CL (Total clearance of the analyte in plasma following intravascular administration)
Time frame: up to 48 hours post dose
Vss (Apparent volume of distribution at steady state following intravascular administration)
Time frame: up to 48 hours post dose
Vz (apparent volume of distribution during the terminal phase λz following intravascular administration)
Time frame: up to 48 hours post dose
Amount of parent drug eliminated in urine (Ae)
Time frame: up to 48 hours post dose
Change in activated partial thromboplastin time (aPTT)
Time frame: up to 48 hours post dose
Change in prothrombin time (PT)
Time frame: up to 48 hours post dose
Change in ecarin clotting time (ECT)
Time frame: up to 48 hours post dose
Change in thrombin time (TT)
Time frame: up to 48 hours post dose
Number of subjects with adverse events
Time frame: up to 4 days
Number of subjects with clinically significant changes in vital signs
Time frame: up to 4 days
Pulse rate, systolic \& diastolic blood pressure
Change in International Normalised Ratio (INR)
Time frame: up to 48 hours post dose
Fraction of administered drug excreted unchanged in urine (fe)
Time frame: up to 48 hours post dose
CLR (renal clearance of the analyte in plasma following intravascular administration)
Time frame: up to 48 hours post dose
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 1 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 BIBT 986 BS - low and BIBT 986 BS - high 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 4 inclusion and 22 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 1 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?
Cmax (maximum measured concentration of the analyte in plasma) (time frame: up to 48 hours post dose). The study lists 22 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 1 Oct 2014.