HealthyPhase 1NCT02170805
Bioavailability of BIBR 1048 MS Single Doses With or Without Pantoprazole in Healthy Subjects
A Phase 1 study testing BIBR 1048 MS capsule formulation A, BIBR 1048 MS capsule formulation B and BIBR 1048 MS powder plus solution in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule formulation using melt extrusion technology was assessed in two separate, single dose, 3-way crossover, open design, randomised studies. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBR 1048 MS capsule formulation A, BIBR 1048 MS capsule formulation B and BIBR 1048 MS powder plus solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Jun 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 55 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 ≤ 55 years
- Broca ≥ - 20% and ≤ + 20%
Who cannot join
- Any findings 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, 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
- 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 trial
- Participation in another trial with an investigational drug within 2 months 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 Two Different 50 mg Capsules of BIBR 1048 MS With and Without Coadministration of Pantoprazole to Healthy Subjects Relative to Solution. Two Groups, 3-way Crossover, Randomised, Open Trial
The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule formulation using melt extrusion technology was assessed in two separate, single dose, 3-way crossover, open design, randomised studies. The 3-way crossover treatments included administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A or B and administration of the capsules with coadministration of pantoprazole.
- Conditions
- Healthy
- Being tested
- BIBR 1048 MS capsule formulation A, BIBR 1048 MS capsule formulation B, BIBR 1048 MS powder plus solution, Pantoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 1048 MS capsule formulation ADrug
BIBR 1048 MS, formulation A 50 mg
BIBR 1048 MS capsule formulation BDrug
BIBR 1048 MS, formulation B 50 mg
BIBR 1048 MS powder plus solutionDrug
BIBR 1048 MS, powder plus solution 50 mg
PantoprazoleDrug
Also called Pantozol®
Pantoprazole 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1 | Experimental | Three treatments of single administrations of BIBR 1048 MS 50 mg with or without pantoprazole; randomised sequence
1. BIBR 1048 MS capsule formulation A without pantoprazole;
2. BIBR 1048 MS capsule formulation A with coadministration of 40 mg pantoprazole (bid);
3. BIBR 1048 MS powder plus solution without pantoprazole Receives: Drug: BIBR 1048 MS capsule formulation A; Drug: BIBR 1048 MS powder plus solution; Drug: Pantoprazole |
| Substudy 2 | Experimental | Three treatments of single administrations of BIBR 1048 MS 50 mg with or without pantoprazole; randomised sequence
1. BIBR 1048 MS capsule formulation B without pantoprazole;
2. BIBR 1048 MS capsule formulation B with coadministration of 40 mg pantoprazole (bid);
3. BIBR 1048 MS powder plus solution without pantoprazole Receives: Drug: BIBR 1048 MS capsule formulation B; Drug: BIBR 1048 MS powder plus solution; Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (Area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
AUC0-tf (Area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable concentration) of BIBR 953 ZW
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
Secondary outcomes (9)
Cmax (Maximum measured concentration) of BIBR 953 ZW
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
tmax (Time from dosing to the maximum concentration) of BIBR 953 ZW
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
t1/2 (Terminal half-life) of BIBR 953 ZW
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
MRTtot (Total mean residence time) of BIBR 953 ZW
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
CLtot/F (Total apparent clearance) of BIBR 953 ZW
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
Vz/F (Apparent volume of distribution) of BIBR 953 ZW
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
λz (terminal elimination rate constant) of BIBR 953 ZW
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
Changes in aPTT (activated partial thromboplastin time)
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
Changes in PT (prothrombin time)
Measured: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
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 startApr 2001
- Primary completionJun 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
- 24 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
- NCT02170805
- Sponsor's protocol ID
- 1160.17
- 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 Two Different 50 mg Capsules of BIBR 1048 MS With and Without Coadministration of Pantoprazole to Healthy Subjects Relative to Solution. Two Groups, 3-way Crossover, Randomised, Open Trial
- ClinicalTrials.gov ID
- NCT02170805
- Acronym / sponsor ID
- 1160.17
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Jun 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.
The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule formulation using melt extrusion technology was assessed in two separate, single dose, 3-way crossover, open design, randomised studies. The 3-way crossover treatments included administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A or B and administration of the capsules with coadministration of pantoprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substudy 1 | Experimental | Drug: BIBR 1048 MS capsule formulation A, Drug: BIBR 1048 MS powder plus solution, Drug: PantoprazoleThree treatments of single administrations of BIBR 1048 MS 50 mg with or without pantoprazole; randomised sequence 1. BIBR 1048 MS capsule formulation A without pantoprazole; 2. BIBR 1048 MS capsule formulation A with coadministration of 40 mg pantoprazole (bid); 3. BIBR 1048 MS powder plus solution without pantoprazole |
| Substudy 2 | Experimental | Drug: BIBR 1048 MS capsule formulation B, Drug: BIBR 1048 MS powder plus solution, Drug: PantoprazoleThree treatments of single administrations of BIBR 1048 MS 50 mg with or without pantoprazole; randomised sequence 1. BIBR 1048 MS capsule formulation B without pantoprazole; 2. BIBR 1048 MS capsule formulation B with coadministration of 40 mg pantoprazole (bid); 3. BIBR 1048 MS powder plus solution without pantoprazole |
Who may qualify
- Ages
- 18 to 55 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 ≤ 55 years
- Broca ≥ - 20% and ≤ + 20%
Key exclusion criteria (21 listed)
- Any findings 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, 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 capsule formulation ABIBR 1048 MS, formulation A 50 mg | Drug | Substudy 1 |
| BIBR 1048 MS capsule formulation BBIBR 1048 MS, formulation B 50 mg | Drug | Substudy 2 |
| BIBR 1048 MS powder plus solutionBIBR 1048 MS, powder plus solution 50 mg | Drug | Substudy 1, Substudy 2 |
| PantoprazoleAlso: Pantozol®Pantoprazole 40 mg | Drug | Substudy 1, Substudy 2 |
Primary outcome
AUC0-∞ (Area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
AUC0-tf (Area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable concentration) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
9 secondary outcomes
Cmax (Maximum measured concentration) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
tmax (Time from dosing to the maximum concentration) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
t1/2 (Terminal half-life) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
MRTtot (Total mean residence time) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
CLtot/F (Total apparent clearance) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
Vz/F (Apparent volume of distribution) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
λz (terminal elimination rate constant) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
Changes in aPTT (activated partial thromboplastin time)
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
Changes in PT (prothrombin time)
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug
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 capsule formulation A, BIBR 1048 MS capsule formulation B and BIBR 1048 MS powder plus solution 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?
AUC0-∞ (Area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW (time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours after administration of study drug). 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.