HealthyPhase 1NCT02170740
Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects
A Phase 1 study testing BIBR 1048 MS - low dose, BIBR 1048 MS - high dose and BIBR 1048 MS + Pantoprazole in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBR 1048 MS - low dose, BIBR 1048 MS - high dose and BIBR 1048 MS + Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to Jan 2000
- 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 50 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 GCP and local legislation
- Age ≥ 18 and ≤ 50 years
- Broca ≥ - 20% and ≤ + 20%
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- History of orthostatic hypotension, fainting spells and blackouts
- 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
- History of any bleeding disorder including prolonged or habitual bleeding
- History of other hematologic disease
- History of cerebral bleeding (e.g. after a car accident)
- History of commotio cerebri
- Intake of drugs with a long-life (> 24 hours) within 1 month prior to administration
- Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with 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 (> 60g/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 familiar bleeding disorder
- Thrombocytes < 150000/µl
About this study
Official title: Bioavailability of BIBR 953 ZW After Multiple Oral Doses of 50 and 200 mg BIBR 1048 MS Film-coated Tablet Administered BIDfor 3 Days or 200 mg BIBR 1048 MS With and Without Pre-treatment With Pantoprazole to Healthy Volunteer Subjects. Two Groups, 2-way Crossover, Randomised, Open Trial
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.
- Conditions
- Healthy
- Being tested
- BIBR 1048 MS - low dose, BIBR 1048 MS - high dose, BIBR 1048 MS + Pantoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 1048 MS - low doseDrug
BIBR 1048 MS - high doseDrug
BIBR 1048 MS + PantoprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 MS | Experimental | Not described Receives: Drug: BIBR 1048 MS - low dose; Drug: BIBR 1048 MS - high dose |
| BIBR 1048 MS + Pantoprazole | Experimental | Not described Receives: Drug: BIBR 1048 MS - high dose; Drug: BIBR 1048 MS + Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of total BIBR 953 ZW
Measured: Day 1, day 2, day 3 (different time points)
Peak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW
Measured: Day 1, day 2, day 3 (different time points)
Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW
Measured: Day 1, day 2, day 3 (different time points)
Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval
Measured: Day 1, day 2, day 3 (different time points)
Secondary outcomes (9)
Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZW
Measured: Day 1, day 2, day 3 (different time points)
Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration
Measured: Day 1, day 2, day 3 (different time points)
Occurence of adverse events
Measured: 6 weeks
Change from Baseline in pulse rate
Measured: Baseline, day 1,day 2, day 3, day 4
Change from Baseline in systolic and diastolic blood pressure
Measured: Baseline, day 1,day 2, day 3, day 4
Change from Baseline in clinical laboratory tests
Measured: Baseline, day 1,day 2, day 3, day 4
Changes from baseline in activated partial thromboplastin time (aPTT)
Measured: Day 1, day 2, day 3 (different time points)
Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR))
Measured: Day 1, day 2, day 3 (different time points)
Total mean residence time (MRTtot) of BIBR 953 ZW after oral administration
Measured: ay 1, day 2, day 3 (different time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startNov 1999
- Primary completionJan 2000
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
- 26 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
- NCT02170740
- Sponsor's protocol ID
- 1160.14
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of BIBR 953 ZW After Multiple Oral Doses of 50 and 200 mg BIBR 1048 MS Film-coated Tablet Administered BIDfor 3 Days or 200 mg BIBR 1048 MS With and Without Pre-treatment With Pantoprazole to Healthy Volunteer Subjects. Two Groups, 2-way Crossover, Randomised, Open Trial
- ClinicalTrials.gov ID
- NCT02170740
- Acronym / sponsor ID
- 1160.14
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Primary completion
- Jan 2000 (actual)
- First posted
- 23 Jun 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 safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 MS | Experimental | Drug: BIBR 1048 MS - low dose, Drug: BIBR 1048 MS - high dose |
| BIBR 1048 MS + Pantoprazole | Experimental | Drug: BIBR 1048 MS - high dose, Drug: BIBR 1048 MS + Pantoprazole |
Who may qualify
- Ages
- 18 to 50 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 GCP and local legislation
- Age ≥ 18 and ≤ 50 years
- Broca ≥ - 20% and ≤ + 20%
Key exclusion criteria (21 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
- History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
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 |
|---|---|---|
| BIBR 1048 MS - low dose | Drug | BIBR 1048 MS |
| BIBR 1048 MS - high dose | Drug | BIBR 1048 MS, BIBR 1048 MS + Pantoprazole |
| BIBR 1048 MS + Pantoprazole | Drug | BIBR 1048 MS + Pantoprazole |
Primary outcome
Urinary excretion of total BIBR 953 ZW
Time frame: Day 1, day 2, day 3 (different time points)
Peak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW
Time frame: Day 1, day 2, day 3 (different time points)
Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW
Time frame: Day 1, day 2, day 3 (different time points)
Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval
Time frame: Day 1, day 2, day 3 (different time points)
9 secondary outcomes
Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZW
Time frame: Day 1, day 2, day 3 (different time points)
Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration
Time frame: Day 1, day 2, day 3 (different time points)
Occurence of adverse events
Time frame: 6 weeks
Change from Baseline in pulse rate
Time frame: Baseline, day 1,day 2, day 3, day 4
Change from Baseline in systolic and diastolic blood pressure
Time frame: Baseline, day 1,day 2, day 3, day 4
Change from Baseline in clinical laboratory tests
Time frame: Baseline, day 1,day 2, day 3, day 4
Changes from baseline in activated partial thromboplastin time (aPTT)
Time frame: Day 1, day 2, day 3 (different time points)
Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR))
Time frame: Day 1, day 2, day 3 (different time points)
Total mean residence time (MRTtot) of BIBR 953 ZW after oral administration
Time frame: ay 1, day 2, day 3 (different time points)
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 23 Jun 2014.
- Related InfoLink provided by the sponsor.
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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 BIBR 1048 MS - low dose, BIBR 1048 MS - high dose and BIBR 1048 MS + 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 23 Jun 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?
Urinary excretion of total BIBR 953 ZW (time frame: Day 1, day 2, day 3 (different time points)). 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 23 Jun 2014.