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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Clopidogrel; Drug: Terbogrel

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clopidogrel	Drug: Clopidogrel
Active Comparator: Terbogrel	Drug: Terbogrel
Experimental: Terbogrel with Clopidogrel	Drug: Clopidogrel; Drug: Terbogrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Plasma levels of terbogrel		up to day 17
Number of patients with adverse events		up to day 17
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
Number of patients with haematuria	dipstick test	up to day 17
Number of patients with positive Haemoccult test		up to day 17
Number of patients with clinically significant laboratory findings		up to day 17

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 1999
• Primary Completion (Actual): March 1, 1999

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: 528.23