HealthyPhase 1NCT02173730
BIBR 953 ZW in Healthy Elderly Subjects
A Phase 1 study testing BIBR 1048 MS and Pantoprazole in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences. To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953 ZW. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBR 1048 MS and Pantoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Feb 2003
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy male and female elderly subjects as determined by results of screening
- Signed written informed consent in accordance with GCP and local legislation
- Age ≥ 65, no upper limit
- BMI ≥ 18.5 and ≤ 29.9 kg/m2
Who cannot join
- Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- History of relevant 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
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)
- cranio-cerebral trauma
- Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- Use of any drugs that 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 trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- Alcohol intake (>30 - 40 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 < 140000/μl (male) or < 156000/μl (female)
About this study
Official title: Pharmacokinetics of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953) Administered as Capsule Twice Daily Over Seven Days With or Without Pantoprazole Co-treatment to Healthy Male and Female Elderly Subjects
To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences. To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953 ZW.
- Conditions
- Healthy
- Being tested
- 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 MSDrug
BIBR 1048 MS capsule 150 mg
PantoprazoleDrug
Pantoprazole tablet 40 mg
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 MS without Pantoprazole | Experimental | 150 mg BIBR 1048 MS capsules administered twice daily over 6 days and once in the morning of the seventh day Receives: Drug: BIBR 1048 MS |
| BIBR 1048 MS with Pantoprazole | Experimental | 150 mg BIBR 1048 MS capsules administered twice daily over 6 days and once in the morning of the seventh day together with Pantoprazole. Pantoprazole administration (40 mg bid) started two days before administration og BIBR 1048 and ended in the morning of the seventh day. Receives: Drug: BIBR 1048 MS; Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss (area under the plasma concentration time curve during a dosing interval at steady state)
Measured: Day 4 and 7
Cmax,ss (maximum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
Measured: Day 4 and 7
Aeτ,ss (amount of dose excreted in urine over one dosing interval at steady state)
Measured: Day 4 and 7
feτ,ss (percent of dose excreted in urine over one dosing interval at steady state)
Measured: Day 4 and 7
AUC0-tz,ss (area under the plasma concentration time curve (AUC) from zero time (pre dose) to the time of the last quantifiable concentration (tz))
Measured: Day 4 and 7
Cmin,ss (minimum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
Measured: Day 4 and 7
tmax,ss (time from last dosing to the maximum concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
Measured: Day 4 and 7
t½,ss (terminal half-life, calculated from the terminal elimination rate constant)
Measured: Day 4 and 7
Secondary outcomes (7)
CLR,ss (renal clearance at steady state following multiple dose administration)
Measured: Day 4 and 7
MRTss (steady state mean residence time)
Measured: Day 4 and 7
CL/F,ss (apparent clearance of the analyse in plasma at steady state after extravascular multiple dose administration)
Measured: Day 4 and 7
Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)
Measured: Day 4 and 7
Changes in activated partial thromboplastin time (aPTT)
Measured: Day 4 and 7
Changes in ecarin clotting time (ECT)
Measured: Day 4 and 7
Occurrence of Adverse Events
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startNov 2002
- Primary completionFeb 2003
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT02173730
- Sponsor's protocol ID
- 1160.10
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of BIBR 953 ZW After 150 mg of BIBR 1048 (Oral Pro-drug of BIBR 953) Administered as Capsule Twice Daily Over Seven Days With or Without Pantoprazole Co-treatment to Healthy Male and Female Elderly Subjects
- ClinicalTrials.gov ID
- NCT02173730
- Acronym / sponsor ID
- 1160.10
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Feb 2003 (actual)
- First posted
- 25 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 steady state pharmacokinetic profile of BIBR 953 ZW after administration of BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences. To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953 ZW.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 MS without Pantoprazole | Experimental | Drug: BIBR 1048 MS150 mg BIBR 1048 MS capsules administered twice daily over 6 days and once in the morning of the seventh day |
| BIBR 1048 MS with Pantoprazole | Experimental | Drug: BIBR 1048 MS, Drug: Pantoprazole150 mg BIBR 1048 MS capsules administered twice daily over 6 days and once in the morning of the seventh day together with Pantoprazole. Pantoprazole administration (40 mg bid) started two days before administration og BIBR 1048 and ended in the morning of the seventh day. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Healthy male and female elderly subjects as determined by results of screening
- Signed written informed consent in accordance with GCP and local legislation
- Age ≥ 65, no upper limit
- BMI ≥ 18.5 and ≤ 29.9 kg/m2
Key exclusion criteria (22 listed)
- Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- History of relevant 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 MSBIBR 1048 MS capsule 150 mg | Drug | BIBR 1048 MS with Pantoprazole, BIBR 1048 MS without Pantoprazole |
| PantoprazolePantoprazole tablet 40 mg | Drug | BIBR 1048 MS with Pantoprazole |
Primary outcome
AUCτ,ss (area under the plasma concentration time curve during a dosing interval at steady state)
Time frame: Day 4 and 7
Cmax,ss (maximum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
Time frame: Day 4 and 7
Aeτ,ss (amount of dose excreted in urine over one dosing interval at steady state)
Time frame: Day 4 and 7
feτ,ss (percent of dose excreted in urine over one dosing interval at steady state)
Time frame: Day 4 and 7
AUC0-tz,ss (area under the plasma concentration time curve (AUC) from zero time (pre dose) to the time of the last quantifiable concentration (tz))
Time frame: Day 4 and 7
Cmin,ss (minimum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
Time frame: Day 4 and 7
tmax,ss (time from last dosing to the maximum concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
Time frame: Day 4 and 7
t½,ss (terminal half-life, calculated from the terminal elimination rate constant)
Time frame: Day 4 and 7
7 secondary outcomes
CLR,ss (renal clearance at steady state following multiple dose administration)
Time frame: Day 4 and 7
MRTss (steady state mean residence time)
Time frame: Day 4 and 7
CL/F,ss (apparent clearance of the analyse in plasma at steady state after extravascular multiple dose administration)
Time frame: Day 4 and 7
Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)
Time frame: Day 4 and 7
Changes in activated partial thromboplastin time (aPTT)
Time frame: Day 4 and 7
Changes in ecarin clotting time (ECT)
Time frame: Day 4 and 7
Occurrence of Adverse Events
Time frame: up to 10 days
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 25 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 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 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 25 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?
AUCτ,ss (area under the plasma concentration time curve during a dosing interval at steady state) (time frame: Day 4 and 7). The study lists 8 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 25 Jun 2014.