HealthyPhase 1NCT02264106
Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban Over 5 Days in Healthy Subjects
A Phase 1 study testing Lefradafiban tablet, Lefradafiban double chamber sachet and Pantoprazole in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lefradafiban tablet, Lefradafiban double chamber sachet and Pantoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Jun 1998
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age ≥ 18 and ≤ 60 years, planned stratification: age < 40 years (4 subjects) and ≥ 40 years (8 subjects)
- Broca ≥ - 20 % and ≤ + 20 %
Who cannot join
- Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Drug abuse
- Alcohol abuse (> 60 g/day)
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
Show all 21Show fewer
- Excessive physical activities within 5 days prior to administration or during the trial
- Blood donation within 1 month prior to administration or during the trial
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
- Chronic or relevant acute infections
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- 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
- Recent surgical procedures
- Thrombocytes < 150000/µ
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Any laboratory value outside the clinically accepted reference range
- Other disease or abnormality of clinical relevance
About this study
Official title: Influence of 40 mg Pantoprazole Per Day on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of 30 mg Lefradafiban Tid as Acid Free Tablet and Sachet Over 5 Days in Healthy Subjects. A 4-way Crossover Randomized Open Trial
To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole
- Conditions
- Healthy
- Being tested
- Lefradafiban tablet, Lefradafiban double chamber sachet, Pantoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lefradafiban tabletDrug
Lefradafiban double chamber sachetDrug
PantoprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Lefradafiban tablet with pantoprazole | Experimental | Not described Receives: Drug: Lefradafiban tablet; Drug: Pantoprazole |
| Lefradafiban tablet | Active comparator | Not described Receives: Drug: Lefradafiban tablet |
| Lefradafiban double chamber sachet with pantoprazole | Experimental | Not described Receives: Drug: Lefradafiban double chamber sachet; Drug: Pantoprazole |
| Lefradafiban double chamber sachet | Active comparator | Not described Receives: Drug: Lefradafiban double chamber sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13)
Measured: Up to 168 hours after first drug administration
Maximum concentration of the analyte in plasma at steady state, 13th dosing interval (Cmax,ss,13)
Measured: Up to 168 hours after first drug administration
Pre-dose concentration of the analyte in plasma at steady state, 13th dosing interval (Cpre,ss,13)
Measured: Up to 168 hours after first drug administration
Amount of the analyte eliminated unchanged in the urine per dosing interval i expressed as percent of applied dose and corrected for molecular weight differences (Ae% (i=1,...,13))
Measured: Up to 168 hours after first drug administration
Secondary outcomes (10)
Pre-dose concentration of the analyte in plasma for the i-th dosing interval (Cpre,i (i=1,4,7,10,11,12))
Measured: Up to 90 hours after first drug administration
Plasma concentration of the analyte at 2 hours post-dose for the i-th dosing interval (C2h,i (i=10,11,12))
Measured: Up to 98 hours after first drug administration
Terminal half life of the analyte in plasma (t1/2)
Measured: Up to 168 hours after first drug administration
Percent swing of peak/trough concentrations of the analyte in plasma for the i-th dosing interval (%Swingi)
Calculated: (C2h,i - Cpre,i) / Cpre,i * 100% (i=10,11,12)
Measured: Up to 168 hours after first drug administration
Percent peak-trough fluctuation for the 13th dosing interval (%PTF13)
Calculated: (Cmax,ss,13 - Cpre,ss,13) * 8h / AUCss,13 * 100%)
Measured: Up to 168 hours after first drug administration
Percent fluctuation of area under the plasma concentration-time curve (AUCfluc,13)
Calculated: (AUCabove,13 - AUCbelow,13) / AUCabove,13
Measured: Up to 168 hours after first drug administration
Fibrinogen receptor occupancy levels
Measured: Up to 168 hours after first drug administration
Number of patients with clinically relevant findings in laboratory tests
Measured: up to 168 hours after first drug administration
Number of patients with clinically relevant findings in vital signs
systolic and diastolic blood pressure, pulse rate
Measured: up to day 8 after first drug administration
Number of patients with adverse events
Measured: Up to 3 days after last 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 startApr 1998
- Primary completionJun 1998
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02264106
- Sponsor's protocol ID
- 509.118
- Status last verified
- Oct 2014
- First submitted
- 13 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 40 mg Pantoprazole Per Day on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of 30 mg Lefradafiban Tid as Acid Free Tablet and Sachet Over 5 Days in Healthy Subjects. A 4-way Crossover Randomized Open Trial
- ClinicalTrials.gov ID
- NCT02264106
- Acronym / sponsor ID
- 509.118
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Jun 1998 (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 absorption of 30 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lefradafiban tablet with pantoprazole | Experimental | Drug: Lefradafiban tablet, Drug: Pantoprazole |
| Lefradafiban tablet | Active comparator | Drug: Lefradafiban tablet |
| Lefradafiban double chamber sachet with pantoprazole | Experimental | Drug: Lefradafiban double chamber sachet, Drug: Pantoprazole |
| Lefradafiban double chamber sachet | Active comparator | Drug: Lefradafiban double chamber sachet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age ≥ 18 and ≤ 60 years, planned stratification: age < 40 years (4 subjects) and ≥ 40 years (8 subjects)
- Broca ≥ - 20 % and ≤ + 20 %
Key exclusion criteria (21 listed)
- Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Drug abuse
- Alcohol abuse (> 60 g/day)
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 tablet | Drug | Lefradafiban tablet, Lefradafiban tablet with pantoprazole |
| Lefradafiban double chamber sachet | Drug | Lefradafiban double chamber sachet, Lefradafiban double chamber sachet with pantoprazole |
| Pantoprazole | Drug | Lefradafiban double chamber sachet with pantoprazole, Lefradafiban tablet with pantoprazole |
Primary outcome
Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13)
Time frame: Up to 168 hours after first drug administration
Maximum concentration of the analyte in plasma at steady state, 13th dosing interval (Cmax,ss,13)
Time frame: Up to 168 hours after first drug administration
Pre-dose concentration of the analyte in plasma at steady state, 13th dosing interval (Cpre,ss,13)
Time frame: Up to 168 hours after first drug administration
Amount of the analyte eliminated unchanged in the urine per dosing interval i expressed as percent of applied dose and corrected for molecular weight differences (Ae% (i=1,...,13))
Time frame: Up to 168 hours after first drug administration
10 secondary outcomes
Pre-dose concentration of the analyte in plasma for the i-th dosing interval (Cpre,i (i=1,4,7,10,11,12))
Time frame: Up to 90 hours after first drug administration
Plasma concentration of the analyte at 2 hours post-dose for the i-th dosing interval (C2h,i (i=10,11,12))
Time frame: Up to 98 hours after first drug administration
Terminal half life of the analyte in plasma (t1/2)
Time frame: Up to 168 hours after first drug administration
Percent swing of peak/trough concentrations of the analyte in plasma for the i-th dosing interval (%Swingi)
Time frame: Up to 168 hours after first drug administration
Percent peak-trough fluctuation for the 13th dosing interval (%PTF13)
Time frame: Up to 168 hours after first drug administration
Percent fluctuation of area under the plasma concentration-time curve (AUCfluc,13)
Time frame: Up to 168 hours after first drug administration
Fibrinogen receptor occupancy levels
Time frame: Up to 168 hours after first drug administration
Number of patients with clinically relevant findings in laboratory tests
Time frame: up to 168 hours after first drug administration
Number of patients with clinically relevant findings in vital signs
Time frame: up to day 8 after first drug administration
Number of patients with adverse events
Time frame: Up to 3 days after last 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 tablet, Lefradafiban double chamber sachet and Pantoprazole 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?
Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13) (time frame: Up to 168 hours after first drug administration). The study lists 4 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.