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

Phase 1

Completed

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

• Registration Number: NCT02265289
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Primary Completion: 1999-02
• Status Verified: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Last Update Submitted: 2014-10-14
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-15

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma (AUC)	Up to 383:30 hours after first drug administration
Inhibition of platelet aggregation in platelet rich plasma (PRP)	Up to 383:30 hours after first drug administration
Maximum concentration of the analyte in plasma at steady state (Cmax)	Up to 383:30 hours after first drug administration
Amount of the analyte excreted unchanged in the urine (Ae)	Up to 176:00 hours after first drug administration
Fibrinogen receptor occupancy levels (FRO)	Up to 383:30 hours after first drug administration

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in 12-lead ECG	Pre-dose and 384:30 hours after first drug administration
Number of subjects with clinically significant findings in vital signs	up to 5 days after last drug administration	systolic and diastolic blood pressure, pulse rate
Number of subjects with adverse events	up to 5 days after last drug administration
Changes from baseline in bleeding time	Pre-dose and 384:30 hours after first drug administration