Clinical trial NCT02170740: Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects
Official title: Bioavailability of BIBR 953 ZW After Multiple Oral Doses of 50 and 200 mg BIBR 1048 MS Film-coated Tablet Administered BIDfor 3 Days or 200 mg BIBR 1048 MS With and Without Pre-treatment With Pantoprazole to Healthy Volunteer Subjects. Two Groups, 2-way Crossover, Randomised, Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP and local legislation
* Age ≥ 18 and ≤ 50 years
* Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* History of any bleeding disorder including prolonged or habitual bleeding
* History of other hematologic disease
* History of cerebral bleeding (e.g. after a car accident)
* History of commotio cerebri
* Intake of drugs with a long-life (\> 24 hours) within 1 month prior to administration
* Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with investigational drug within 2 months prior to administration or during the trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug 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
* Any laboratory value outside the clinically accepted reference range
* History of any familiar bleeding disorder
* Thrombocytes \< 150000/µl

Primary outcomes:
measure: Urinary excretion of total BIBR 953 ZW
timeFrame: Day 1, day 2, day 3 (different time points)
measure: Peak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW
timeFrame: Day 1, day 2, day 3 (different time points)
measure: Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW
timeFrame: Day 1, day 2, day 3 (different time points)
measure: Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval
timeFrame: Day 1, day 2, day 3 (different time points)
Secondary outcomes:
measure: Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZW
timeFrame: Day 1, day 2, day 3 (different time points)
measure: Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration
timeFrame: Day 1, day 2, day 3 (different time points)
measure: Occurence of adverse events
timeFrame: 6 weeks
measure: Change from Baseline in pulse rate
timeFrame: Baseline, day 1,day 2, day 3, day 4
measure: Change from Baseline in systolic and diastolic blood pressure
timeFrame: Baseline, day 1,day 2, day 3, day 4
measure: Change from Baseline in clinical laboratory tests
timeFrame: Baseline, day 1,day 2, day 3, day 4
measure: Changes from baseline in activated partial thromboplastin time (aPTT)
timeFrame: Day 1, day 2, day 3 (different time points)
measure: Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR))
timeFrame: Day 1, day 2, day 3 (different time points)
measure: Total mean residence time (MRTtot) of BIBR 953 ZW after oral administration
timeFrame: ay 1, day 2, day 3 (different time points)
Other outcomes:
Locations:
Study officials:
References: