HealthyPhase 1NCT02170831
Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers
A Phase 1 study testing BIBR 1048 MS low, BIBR 1048 MS medium 1 and BIBR 1048 MS medium 2 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBR 1048 MS low, BIBR 1048 MS medium 1 and BIBR 1048 MS medium 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 1999to Jul 1999
- 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 45 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 ≤ 45 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
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- 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 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: Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 50, 100, 200, and 400 mg BIBR 1048 MS Solution Administered TID for 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.
- Conditions
- Healthy
- Being tested
- BIBR 1048 MS low, BIBR 1048 MS medium 1, BIBR 1048 MS medium 2, BIBR 1048 MS high, BIBR 1048 MS placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 1048 MS lowDrug
BIBR 1048 MS medium 1Drug
BIBR 1048 MS medium 2Drug
BIBR 1048 MS highDrug
BIBR 1048 MS placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 MS low dose | Experimental | Not described Receives: Drug: BIBR 1048 MS low |
| BIBR 1048 MS medium dose 1 | Experimental | Not described Receives: Drug: BIBR 1048 MS medium 1 |
| BIBR 1048 MS medium dose 2 | Experimental | Not described Receives: Drug: BIBR 1048 MS medium 2 |
| BIBR 1048 MS high dose | Experimental | Not described Receives: Drug: BIBR 1048 MS high |
| BIBR 1048 Placebo | Placebo comparator | Not described Receives: Drug: BIBR 1048 MS placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aPTT (activated partial thromboplastin time)
Measured: up to day 10
Change in PT (prothrombin time)
Measured: up to day 10
Secondary outcomes (13)
Cmax (maximum measured concentration) of BIBR 953 ZW
Measured: up to day 10
tmax (time from dosing to the maximum concentration) of BIBR 953 ZW
Measured: up to day 10
AUC0-∞ (area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW
Measured: up to day 10
Cmax,ss (maximum measured concentration at steady state) of BIBR 953 ZW
Measured: Day 7
Cmin,ss (minimum measured concentration at steady state) of BIBR 953 ZW
Measured: Day 7
Cavg (average plasma concentration at steady state) of BIBR 953 ZW
Measured: up to day 10
PTF (percent peak trough fluctuation for the last dosing interval) of BIBR 953 ZW
Measured: up to day 10
tmax,ss (time to reach Cmax) of BIBR 953 ZW
Measured: up to day 10
t1/2 (terminal half-life) of BIBR 953 ZW
Measured: up to day 10
AUCss (area under the plasma concentration-time curve of one dosing interval at steady state) of BIBR 953 ZW
Measured: up to day 10
MRTss (mean residence time at steady state) of BIBR 953 ZW
Measured: up to day 10
CLtot/F (total apparent clearance) of BIBR 953 ZW
Measured: up to day 10
Vz/F (apparent volume of distribution) of BIBR 953 ZW
Measured: up to day 10
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 startMay 1999
- Primary completionJul 1999
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
- 40 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
- NCT02170831
- Sponsor's protocol ID
- 1160.2
- 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
- Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 50, 100, 200, and 400 mg BIBR 1048 MS Solution Administered TID for 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level
- ClinicalTrials.gov ID
- NCT02170831
- Acronym / sponsor ID
- 1160.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 1999
- Primary completion
- Jul 1999 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 MS low dose | Experimental | Drug: BIBR 1048 MS low |
| BIBR 1048 MS medium dose 1 | Experimental | Drug: BIBR 1048 MS medium 1 |
| BIBR 1048 MS medium dose 2 | Experimental | Drug: BIBR 1048 MS medium 2 |
| BIBR 1048 MS high dose | Experimental | Drug: BIBR 1048 MS high |
| BIBR 1048 Placebo | Placebo comparator | Drug: BIBR 1048 MS placebo |
Who may qualify
- Ages
- 18 to 45 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 ≤ 45 years
- Broca ≥ -20% and ≤ +20%
Key exclusion criteria (22 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 low | Drug | BIBR 1048 MS low dose |
| BIBR 1048 MS medium 1 | Drug | BIBR 1048 MS medium dose 1 |
| BIBR 1048 MS medium 2 | Drug | BIBR 1048 MS medium dose 2 |
| BIBR 1048 MS high | Drug | BIBR 1048 MS high dose |
| BIBR 1048 MS placebo | Drug | BIBR 1048 Placebo |
Primary outcome
Change in aPTT (activated partial thromboplastin time)
Time frame: up to day 10
Change in PT (prothrombin time)
Time frame: up to day 10
13 secondary outcomes
Cmax (maximum measured concentration) of BIBR 953 ZW
Time frame: up to day 10
tmax (time from dosing to the maximum concentration) of BIBR 953 ZW
Time frame: up to day 10
AUC0-∞ (area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW
Time frame: up to day 10
Cmax,ss (maximum measured concentration at steady state) of BIBR 953 ZW
Time frame: Day 7
Cmin,ss (minimum measured concentration at steady state) of BIBR 953 ZW
Time frame: Day 7
Cavg (average plasma concentration at steady state) of BIBR 953 ZW
Time frame: up to day 10
PTF (percent peak trough fluctuation for the last dosing interval) of BIBR 953 ZW
Time frame: up to day 10
tmax,ss (time to reach Cmax) of BIBR 953 ZW
Time frame: up to day 10
t1/2 (terminal half-life) of BIBR 953 ZW
Time frame: up to day 10
AUCss (area under the plasma concentration-time curve of one dosing interval at steady state) of BIBR 953 ZW
Time frame: up to day 10
MRTss (mean residence time at steady state) of BIBR 953 ZW
Time frame: up to day 10
CLtot/F (total apparent clearance) of BIBR 953 ZW
Time frame: up to day 10
Vz/F (apparent volume of distribution) of BIBR 953 ZW
Time frame: up to day 10
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, BIBR 1048 MS medium 1 and BIBR 1048 MS medium 2 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. Some participants in this study may receive a placebo. 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?
Change in aPTT (activated partial thromboplastin time) (time frame: up to day 10). 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; AzTrials last refreshed its copy on 6 Nov 2026.