Clinical trial NCT02254057: Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses BIBT 986 BS in Healthy Male Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
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)
timeFrame: up to 48 hours after start of infusion
measure: 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)
timeFrame: up to 48 hours after start of infusion
measure: C29 (plasma concentration of BIBT 986 BS at the end of infusion)
timeFrame: 29 minutes after start of infusion
measure: t1/2 (Terminal half-life of the analyte in plasma after single dose administration)
timeFrame: up to 48 hours after start of infusion
measure: CL (Total clearance of the analyte in plasma following intravascular administration)
timeFrame: up to 48 hours after start of infusion
measure: Vss (Apparent volume of distribution at steady state following intravascular administration)
timeFrame: up to 48 hours after start of infusion
measure: urinary excretion of BIBT 986 BS
timeFrame: up to 48 hours after start of infusion
measure: CLR (Renal clearance of the analyte in plasma following intravascular administration)
timeFrame: up to 48 hours after start of infusion
measure: MRT (Mean residence time of drug molecules in the body after intravascular administration)
timeFrame: up to 48 hours after start of infusion
measure: Change in activated partial thromboplastin time (aPTT)
timeFrame: up to 48 hours after start of infusion
measure: Change in International Normalised Ratio (INR)
timeFrame: up to 48 hours after start of infusion
measure: Change in ecarin clotting time (ECT)
timeFrame: up to 48 hours after start of infusion
measure: Change in thrombin time (TT)
timeFrame: up to 48 hours after start of infusion
measure: Number of patients with clinically significant findings in vital signs
timeFrame: up to 48 hours after start of infusion
measure: Number of patients with clinically significant findings in electrocardiogram
timeFrame: up to 48 hours after start of infusion
measure: Number of patients with clinically significant findings in laboratory tests
timeFrame: up to 48 hours after start of infusion
measure: Number of patients with adverse events
timeFrame: up to 48 hours after start of infusion
measure: Number of patients with histamine in blood
timeFrame: up to 48 hours after start of infusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: