Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Terbogrel; Drug: Clopidogrel

• Registration Number: NCT02222987
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-02
• Primary Completion: 1999-03
• Status Verified: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Study First Posted: 2014-08-22
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Terbogrel with Clopidogrel	Terbogrel	-
Terbogrel	Terbogrel	-
Terbogrel with Clopidogrel	Clopidogrel	-
Clopidogrel	Clopidogrel	-

Primary Outcome Measures

Name	Time	Method
Change in inhibition of platelet aggregation in platelet rich plasma (PRP)	baseline, up to day 17
Change in thromboxane receptor occupancy (TRO)	baseline, up to day 17
Change in 6-keto-prostaglandinF-1-alpha	baseline, up to day 17
Change in thromboxan synthesis inhibition (TSI)	baseline, up to day 17

Secondary Outcome Measures

Name	Time	Method
Change in bleeding time	baseline, up to day 17
Change in systolic and diastolic blood pressure	baseline, up to day 17
Change in pulse rate	baseline, up to day 17
Plasma levels of terbogrel	up to day 17
Number of patients with adverse events	up to day 17
Number of patients with haematuria	up to day 17	dipstick test
Number of patients with positive Haemoccult test	up to day 17
Number of patients with clinically significant laboratory findings	up to day 17