Clinical trial NCT02265289: Influence of Clopidogrel on the Pharmacodynamics and Safety of Fradafiban in Healthy Male Subjects
Official title: Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Fradafiban After Oral Doses of 30 mg Lefradafiban Tid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid


Eligibility criteria: Inclusion Criteria:

* Written informed consent in accordance with good clinical practice (GCP) and local legislation
* Healthy male subjects
* Age ≥ 18 and ≤ 45 years
* Broca ≥ - 20 % and ≤ + 20 %

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
* 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 the 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: Inhibition of platelet aggregation in platelet rich plasma (PRP)
timeFrame: Up to 383:30 hours after first drug administration
measure: Fibrinogen receptor occupancy levels (FRO)
timeFrame: Up to 383:30 hours after first drug administration
measure: Maximum concentration of the analyte in plasma at steady state (Cmax)
timeFrame: Up to 383:30 hours after first drug administration
measure: Area under the concentration-time curve of the analyte in plasma (AUC)
timeFrame: Up to 383:30 hours after first drug administration
measure: Amount of the analyte excreted unchanged in the urine (Ae)
timeFrame: Up to 176:00 hours after first drug administration
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 5 days after last drug administration
measure: Changes from baseline in 12-lead ECG
timeFrame: Pre-dose and 384:30 hours after first drug administration
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: up to 5 days after last drug administration
measure: Changes from baseline in bleeding time
timeFrame: Pre-dose and 384:30 hours after first drug administration
Other outcomes:
Locations:
Study officials:
References: