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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lefradafiban; Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02265289

509.302

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Lefradafiban with clopidogrel

Experimental group

Description:

All patients received the same treatment: * Lefradafiban only (day 1-4) * Lefradafiban in combination with Clopidogrel (day 5-8) * Clopidogrel only (day 9-12)

Treatment:

Drug: Lefradafiban

Drug: Clopidogrel