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

NCT ID: NCT02265289

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lefradafiban with clopidogrel

All patients received the same treatment:

• Lefradafiban only (day 1-4)
• Lefradafiban in combination with Clopidogrel (day 5-8)
• Clopidogrel only (day 9-12)

Group Type: EXPERIMENTAL

Lefradafiban

Intervention Type: DRUG

Clopidogrel

Intervention Type: DRUG

Interventions

Lefradafiban

Intervention Type: DRUG

Clopidogrel

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

509.302

Identifier Type: -

Identifier Source: org_study_id