HealthyPhase 1NCT02170792
Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS
A Phase 1 study testing BIBR 1048 MS and Ranitidine in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine. 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 and Ranitidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Mar 2001
- 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 <0 + 20%
Who cannot join
- any finding of the medical examination (including blood pressure, pulse rate and ECG)
- history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- history of orthostatic hypotension, fainting spells and blackouts
- diseases of central nervous system (such as epilepsy) or psychiatric disorders
- chronic or relevant acute infections
- History of:
Show all 22Show fewer
- 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 administration
- participation in another trial with an investigational drug within 2 month prior to administration or during 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: Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Groups, 2-way Crossover, Randomised, Open Trial.
To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.
- Conditions
- Healthy
- Being tested
- BIBR 1048 MS, Ranitidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 1048 MSDrug
Low, medium or high dose
RanitidineDrug
Also called Zantic ®
150mg
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 MS with ranitidine | Experimental | Low, medium or high dose in combination with ranitidine Receives: Drug: BIBR 1048 MS; Drug: Ranitidine |
| BIBR 1048 MS without ranitidine | Experimental | Low, medium or high dose Receives: Drug: BIBR 1048 MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)
Measured: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf)
Measured: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Secondary outcomes (9)
Maximum concentration of drug in plasma ( Cmax )
Measured: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Changes from baseline in Pulse rate
Measured: baseline up to 36 h after last administration
Changes from baseline in blood pressure (systolic and diastolic)
Measured: baseline up to 36 h after last administration
Changes from baseline in ECG
Measured: baseline up to 36 h after last administration
Changes from baseline in routine laboratory
Measured: baseline up to 36 h after last administration
Number of participants with adverse events
Measured: up to 36 h after last administration
Changes in international normalized ratio (INR )
Measured: before and 2 hours after treatment
Changes in activated prothrombin time (aPTT)
Measured: before and 2 hours after treatment
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 startFeb 2001
- Primary completionMar 2001
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
- 30 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
- NCT02170792
- Sponsor's protocol ID
- 1160.16
- 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 Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Groups, 2-way Crossover, Randomised, Open Trial.
- ClinicalTrials.gov ID
- NCT02170792
- Acronym / sponsor ID
- 1160.16
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Mar 2001 (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 the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 MS with ranitidine | Experimental | Drug: BIBR 1048 MS, Drug: RanitidineLow, medium or high dose in combination with ranitidine |
| BIBR 1048 MS without ranitidine | Experimental | Drug: BIBR 1048 MSLow, medium or high dose |
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 <0 + 20%
Key exclusion criteria (22 listed)
- any finding of the medical examination (including blood pressure, pulse rate and ECG)
- history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- history of orthostatic hypotension, fainting spells and blackouts
- diseases of 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 MSLow, medium or high dose | Drug | BIBR 1048 MS with ranitidine, BIBR 1048 MS without ranitidine |
| RanitidineAlso: Zantic ®150mg | Drug | BIBR 1048 MS with ranitidine |
Primary outcome
Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)
Time frame: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf)
Time frame: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
9 secondary outcomes
Maximum concentration of drug in plasma ( Cmax )
Time frame: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Changes from baseline in Pulse rate
Time frame: baseline up to 36 h after last administration
Changes from baseline in blood pressure (systolic and diastolic)
Time frame: baseline up to 36 h after last administration
Changes from baseline in ECG
Time frame: baseline up to 36 h after last administration
Changes from baseline in routine laboratory
Time frame: baseline up to 36 h after last administration
Number of participants with adverse events
Time frame: up to 36 h after last administration
Changes in international normalized ratio (INR )
Time frame: before and 2 hours after treatment
Changes in activated prothrombin time (aPTT)
Time frame: before and 2 hours after treatment
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.
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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 and Ranitidine 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 22 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?
Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h) (time frame: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment). The study lists 2 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.