Clinical trial NCT02222987: Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects
Official title: Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Oral Doses of 100 mg Terbogrel Bid 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: 2014-08-22
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.


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 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, immunological or 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 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 days 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 (\> 60 g/day) abuse
* 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 reference range of clinical relevance
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl

Primary outcomes:
measure: Change in inhibition of platelet aggregation in platelet rich plasma (PRP)
timeFrame: baseline, up to day 17
measure: Change in thromboxane receptor occupancy (TRO)
timeFrame: baseline, up to day 17
measure: Change in 6-keto-prostaglandinF-1-alpha
timeFrame: baseline, up to day 17
measure: Change in thromboxan synthesis inhibition (TSI)
timeFrame: baseline, up to day 17
Secondary outcomes:
measure: Plasma levels of terbogrel
timeFrame: up to day 17
measure: Number of patients with adverse events
timeFrame: up to day 17
measure: Change in bleeding time
timeFrame: baseline, up to day 17
measure: Change in systolic and diastolic blood pressure
timeFrame: baseline, up to day 17
measure: Change in pulse rate
timeFrame: baseline, up to day 17
measure: Number of patients with haematuria
timeFrame: up to day 17
measure: Number of patients with positive Haemoccult test
timeFrame: up to day 17
measure: Number of patients with clinically significant laboratory findings
timeFrame: up to day 17
Other outcomes:
Locations:
Study officials:
References: