Clinical trial NCT02182037: Safety, Pharmacodynamics, and Pharmacokinetics of BIBT 1011 BS in Healthy Subjects
Official title: Safety, Pharmacodynamics, and Pharmacokinetics After Single Oral Administration of 1, 5, 10, 30, 100, 200 and 400 mg BIBT 1011 BS as Drinking Solution in Healthy Subjects. An Open, Placebo-controlled, Randomised Study, 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: 2014-07-08
Enrollment: 56
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: A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011 BS, on 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 ≤ 45 years
* Body Mass Index ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Any finding 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, immunological, hormonal disorders
* History of orthostatic hypotension, fainting spells or 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 the 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: Determination of activated partial thromboplastin time (aPTT)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Determination of international normalized ration (INR)
timeFrame: Pre-dose, up to 48 hours after start of treatment
Secondary outcomes:
measure: Determination of thrombin time (TT)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Determination of ecarin clotting time (ECT)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Assessment of plasma concentration time profiles of BIBT 986 BS
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Maximum concentration of BIBT 986 BS in plasma (Cmax)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Area under the concentration time curve for BIBT 986 BS (AUC)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Time from dosing to when the plasma concentration reaches Cmax after a single extravascular dose (tmax)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Total mean time of residence of BIBT 986 BS- molecules in the body (MRTtot)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Apparent volume of distribution of the analytes during the terminal phase (Vz/f)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Terminal elimination half life of BIBT 986 BS in plasma (t1/2)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Amount excreted over the 24 hour sampling period (Ae0-24)
timeFrame: Pre-dose, up to 24 hours after start of treatment
measure: Total clearance after oral administration (CLtot/F)
timeFrame: Pre-dose, up to 48 hours after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to 17 days
measure: Assessment of BIBT 986 BS plasma concentration- aPTT relationship
timeFrame: Pre-dose, up to 48 hours after start of treatment
Other outcomes:
Locations:
Study officials:
References: