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

NCT02265289 | Completed Phase 1

• 1 other identifier: 509.302
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Inhibition of platelet aggregation in platelet rich plasma (PRP)

  Up to 383:30 hours after first drug administration

• Fibrinogen receptor occupancy levels (FRO)

  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

• Area under the concentration-time curve of the analyte in plasma (AUC)

  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

Secondary Outcomes (4)

• Number of subjects with adverse events

  up to 5 days after last drug administration

• 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

• Changes from baseline in bleeding time

  Pre-dose and 384:30 hours after first drug administration

Study Arms (1)

Lefradafiban with clopidogrel

EXPERIMENTAL

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

Drug: Lefradafiban; Drug: Clopidogrel

Interventions

Lefradafiban DRUG

Lefradafiban with clopidogrel

Clopidogrel DRUG

Lefradafiban with clopidogrel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 %

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

lefradafiban; Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 15, 2014
• Study Start: January 1, 1999
• Primary Completion: February 1, 1999
• Last Updated: October 15, 2014

Record last verified: 2014-10