HealthyPhase 1NCT02254057
Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses BIBT 986 BS in Healthy Male Subjects
A Phase 1 study testing BIBT 986 BS - single rising dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS 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 - single rising dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Oct 2002
- 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
- Any bleeding disorder including prolonged or habitual bleeding
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- History of other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Seasonal rhinitis
- Thrombocytes < 150000/μl
- Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
- Use of any drugs, which might influence the results of the trial (< 10 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
- Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco < 5 days prior to administration of study drug or during trial
- 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
- Any ECG value outside of the reference range of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
About this study
Official title: Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses of 0.1 mg, 0.3 mg, 1.0 mg, 2.5 mg, 5.0 mg, and 10.0 mg BIBT 986 BS (IV Infusion Over 30 Minutes) in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level
Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters
- Conditions
- Healthy
- Being tested
- BIBT 986 BS - single rising dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBT 986 BS - single rising doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBT 986 BS - single rising dose | Experimental | Not described Receives: Drug: BIBT 986 BS - single rising dose |
| 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.
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 after start of infusion
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 after start of infusion
C29 (plasma concentration of BIBT 986 BS at the end of infusion)
Measured: 29 minutes after start of infusion
t1/2 (Terminal half-life of the analyte in plasma after single dose administration)
Measured: up to 48 hours after start of infusion
CL (Total clearance of the analyte in plasma following intravascular administration)
Measured: up to 48 hours after start of infusion
Vss (Apparent volume of distribution at steady state following intravascular administration)
Measured: up to 48 hours after start of infusion
urinary excretion of BIBT 986 BS
Measured: up to 48 hours after start of infusion
CLR (Renal clearance of the analyte in plasma following intravascular administration)
Measured: up to 48 hours after start of infusion
MRT (Mean residence time of drug molecules in the body after intravascular administration)
Measured: up to 48 hours after start of infusion
Change in activated partial thromboplastin time (aPTT)
Measured: up to 48 hours after start of infusion
Change in International Normalised Ratio (INR)
Measured: up to 48 hours after start of infusion
Change in ecarin clotting time (ECT)
Measured: up to 48 hours after start of infusion
Change in thrombin time (TT)
Measured: up to 48 hours after start of infusion
Number of patients with clinically significant findings in vital signs
pulse rate, blood pressure
Measured: up to 48 hours after start of infusion
Number of patients with clinically significant findings in electrocardiogram
Measured: up to 48 hours after start of infusion
Number of patients with clinically significant findings in laboratory tests
Measured: up to 48 hours after start of infusion
Number of patients with adverse events
Measured: up to 48 hours after start of infusion
Number of patients with histamine in blood
Measured: up to 48 hours after start of infusion
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 startJul 2002
- Primary completionOct 2002
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
- 47 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
- NCT02254057
- Sponsor's protocol ID
- 1192.1
- 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 Single Rising Doses of 0.1 mg, 0.3 mg, 1.0 mg, 2.5 mg, 5.0 mg, and 10.0 mg BIBT 986 BS (IV Infusion Over 30 Minutes) in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level
- ClinicalTrials.gov ID
- NCT02254057
- Acronym / sponsor ID
- 1192.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Oct 2002 (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 BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBT 986 BS - single rising dose | Experimental | Drug: BIBT 986 BS - single rising dose |
| 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 (24 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 - single rising dose | Drug | BIBT 986 BS - single rising dose |
| Placebo | Drug | Placebo |
Primary outcome
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 after start of infusion
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 after start of infusion
C29 (plasma concentration of BIBT 986 BS at the end of infusion)
Time frame: 29 minutes after start of infusion
t1/2 (Terminal half-life of the analyte in plasma after single dose administration)
Time frame: up to 48 hours after start of infusion
CL (Total clearance of the analyte in plasma following intravascular administration)
Time frame: up to 48 hours after start of infusion
Vss (Apparent volume of distribution at steady state following intravascular administration)
Time frame: up to 48 hours after start of infusion
urinary excretion of BIBT 986 BS
Time frame: up to 48 hours after start of infusion
CLR (Renal clearance of the analyte in plasma following intravascular administration)
Time frame: up to 48 hours after start of infusion
MRT (Mean residence time of drug molecules in the body after intravascular administration)
Time frame: up to 48 hours after start of infusion
Change in activated partial thromboplastin time (aPTT)
Time frame: up to 48 hours after start of infusion
Change in International Normalised Ratio (INR)
Time frame: up to 48 hours after start of infusion
Change in ecarin clotting time (ECT)
Time frame: up to 48 hours after start of infusion
Change in thrombin time (TT)
Time frame: up to 48 hours after start of infusion
Number of patients with clinically significant findings in vital signs
Time frame: up to 48 hours after start of infusion
pulse rate, blood pressure
Number of patients with clinically significant findings in electrocardiogram
Time frame: up to 48 hours after start of infusion
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 48 hours after start of infusion
Number of patients with adverse events
Time frame: up to 48 hours after start of infusion
Number of patients with histamine in blood
Time frame: up to 48 hours after start of infusion
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 - single rising dose 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 24 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?
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 after start of infusion). The study lists 18 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.