HealthyPhase 1NCT02265289
Influence of Clopidogrel on the Pharmacodynamics and Safety of Fradafiban in Healthy Male Subjects
A Phase 1 study testing Lefradafiban and Clopidogrel in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lefradafiban and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Feb 1999
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 %
Who cannot join
- 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
Show all 21Show fewer
- 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
About this study
Official 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.
To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid
- Conditions
- Healthy
- Being tested
- Lefradafiban, Clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LefradafibanDrug
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Lefradafiban; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of platelet aggregation in platelet rich plasma (PRP)
Measured: Up to 383:30 hours after first drug administration
Fibrinogen receptor occupancy levels (FRO)
Measured: Up to 383:30 hours after first drug administration
Maximum concentration of the analyte in plasma at steady state (Cmax)
Measured: Up to 383:30 hours after first drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
Measured: Up to 383:30 hours after first drug administration
Amount of the analyte excreted unchanged in the urine (Ae)
Measured: Up to 176:00 hours after first drug administration
Secondary outcomes (4)
Number of subjects with adverse events
Measured: up to 5 days after last drug administration
Changes from baseline in 12-lead ECG
Measured: Pre-dose and 384:30 hours after first drug administration
Number of subjects with clinically significant findings in vital signs
systolic and diastolic blood pressure, pulse rate
Measured: up to 5 days after last drug administration
Changes from baseline in bleeding time
Measured: Pre-dose and 384:30 hours after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJan 1999
- Primary completionFeb 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265289
- Sponsor's protocol ID
- 509.302
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02265289
- Acronym / sponsor ID
- 509.302
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Feb 1999 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lefradafiban with clopidogrel | Experimental | Drug: Lefradafiban, Drug: ClopidogrelAll patients received the same treatment: * Lefradafiban only (day 1-4) * Lefradafiban in combination with Clopidogrel (day 5-8) * Clopidogrel only (day 9-12) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 %
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lefradafiban | Drug | Lefradafiban with clopidogrel |
| Clopidogrel | Drug | Lefradafiban with clopidogrel |
Primary outcome
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
4 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
Changes from baseline in bleeding time
Time frame: Pre-dose and 384:30 hours after first drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lefradafiban and Clopidogrel in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition of platelet aggregation in platelet rich plasma (PRP) (time frame: Up to 383:30 hours after first drug administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.