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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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
clopidogrel
DrugPrimary outcomes
-
Inhibition of platelet aggregation in platelet rich plasma (PRP)
Time frame: Up to 383:30 hours after first drug administration
-
Fibrinogen receptor occupancy levels (FRO)
Time frame: Up to 383:30 hours after first drug administration
-
Maximum concentration of the analyte in plasma at steady state (Cmax)
Time frame: Up to 383:30 hours after first drug administration
-
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: Up to 383:30 hours after first drug administration
-
Amount of the analyte excreted unchanged in the urine (Ae)
Time frame: Up to 176:00 hours after first drug administration
Secondary outcomes
-
Number of subjects with adverse events
Time frame: up to 5 days after last drug administration
-
Changes from baseline in 12-lead ECG
Time frame: Pre-dose and 384:30 hours after first drug administration
-
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
-
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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