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OpenTrials
Completed

NCT Number: NCT02265289

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

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lefradafiban

Drug

clopidogrel

Drug

Primary outcomes

  1. Inhibition of platelet aggregation in platelet rich plasma (PRP)

    Time frame: Up to 383:30 hours after first drug administration

  2. Fibrinogen receptor occupancy levels (FRO)

    Time frame: Up to 383:30 hours after first drug administration

  3. Maximum concentration of the analyte in plasma at steady state (Cmax)

    Time frame: Up to 383:30 hours after first drug administration

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

    Time frame: Up to 383:30 hours after first drug administration

  5. Amount of the analyte excreted unchanged in the urine (Ae)

    Time frame: Up to 176:00 hours after first drug administration

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: up to 5 days after last drug administration

  2. Changes from baseline in 12-lead ECG

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

  3. Number of subjects with clinically significant findings in vital signs

    Time frame: up to 5 days after last drug administration

    systolic and diastolic blood pressure, pulse rate

  4. Changes from baseline in bleeding time

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Fradafiban After Oral Doses of 30 mg Lefradafiban Tid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial.

Important dates

Study start
1999
Primary completion
1999
First posted
Oct 15, 2014
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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