Clinical trial NCT02170831: Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers
Official title: Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 50, 100, 200, and 400 mg BIBR 1048 MS Solution Administered TID for 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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 ≤ 45 years
* Broca ≥ -20% and ≤ +20%

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and 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
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after a car accident)
  * commotio cerebri
* Intake of drugs with a long half-life (\>24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/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 familial bleeding disorder
* Thrombocytes \< 150000/µl

Primary outcomes:
measure: Change in aPTT (activated partial thromboplastin time)
timeFrame: up to day 10
measure: Change in PT (prothrombin time)
timeFrame: up to day 10
Secondary outcomes:
measure: Cmax (maximum measured concentration) of BIBR 953 ZW
timeFrame: up to day 10
measure: tmax (time from dosing to the maximum concentration) of BIBR 953 ZW
timeFrame: up to day 10
measure: AUC0-∞ (area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW
timeFrame: up to day 10
measure: Cmax,ss (maximum measured concentration at steady state) of BIBR 953 ZW
timeFrame: Day 7
measure: Cmin,ss (minimum measured concentration at steady state) of BIBR 953 ZW
timeFrame: Day 7
measure: Cavg (average plasma concentration at steady state) of BIBR 953 ZW
timeFrame: up to day 10
measure: PTF (percent peak trough fluctuation for the last dosing interval) of BIBR 953 ZW
timeFrame: up to day 10
measure: tmax,ss (time to reach Cmax) of BIBR 953 ZW
timeFrame: up to day 10
measure: t1/2 (terminal half-life) of BIBR 953 ZW
timeFrame: up to day 10
measure: AUCss (area under the plasma concentration-time curve of one dosing interval at steady state) of BIBR 953 ZW
timeFrame: up to day 10
measure: MRTss (mean residence time at steady state) of BIBR 953 ZW
timeFrame: up to day 10
measure: CLtot/F (total apparent clearance) of BIBR 953 ZW
timeFrame: up to day 10
measure: Vz/F (apparent volume of distribution) of BIBR 953 ZW
timeFrame: up to day 10
Other outcomes:
Locations:
Study officials:
References: