HealthyPhase 1NCT02170116
Pharmacodynamics, Safety and Pharmacokinetics After Oral Administration of BIBR 1048 MS in Healthy Volunteers
A Phase 1 study testing BIBR 1048 MS dose 1, BIBR 1048 MS dose 2 and BIBR 1048 MS dose 3 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953 ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048 MS, in healthy male subjects. This was the first administration of this substance to humans. 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 dose 1, BIBR 1048 MS dose 2 and BIBR 1048 MS dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 1998to Dec 1998
- 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 Good Clinical Practice (GCP) and local legislation
- Age >= 18 and <= 45 years
- Broca >= - 20 % and <= + 20 %
Who cannot join
- Any finding 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 or 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)
- commotion 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 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 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: Pharmacodynamics, Safety and Pharmacokinetics After Single Oral Administration of 10, 30, 100, 200 and 400 mg BIBR 1048 MS as Drinking Solution in Healthy Subjects. An Open Study, Placebo Randomized Double Blind at Each Dose Level.
The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953 ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048 MS, in healthy male subjects. This was the first administration of this substance to humans.
- Conditions
- Healthy
- Being tested
- BIBR 1048 MS dose 1, BIBR 1048 MS dose 2, BIBR 1048 MS dose 3, BIBR 1048 MS dose 4, BIBR 1048 MS dose 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 1048 MS dose 1Drug
BIBR 1048 MS dose 2Drug
BIBR 1048 MS dose 3Drug
BIBR 1048 MS dose 4Drug
BIBR 1048 MS dose 5Drug
Placebo to BIBR 1048 MSDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 MS dose 1 | Experimental | Not described Receives: Drug: BIBR 1048 MS dose 1 |
| BIBR 1048 MS dose 2 | Experimental | Not described Receives: Drug: BIBR 1048 MS dose 2 |
| BIBR 1048 MS dose 3 | Experimental | Not described Receives: Drug: BIBR 1048 MS dose 3 |
| BIBR 1048 MS dose 4 | Experimental | Not described Receives: Drug: BIBR 1048 MS dose 4 |
| BIBR 1048 MS dose 5 | Experimental | Not described Receives: Drug: BIBR 1048 MS dose 5 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo to BIBR 1048 MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR))
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after administration
Changes from baseline in activated partial thromboplastin time (aPTT)
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after administration
Secondary outcomes (15)
Peak (maximum) plasma concentration (Cmax) of BIBR 953 ZW
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
time to reach the peak plasma concentration (tmax ) of BIBR 953 ZW
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
AUC0-12 h - Area under the plasma concentration-time curve of BIBR 953 ZW from 0 to 12 h
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Area under the plasma concentration-time curve (AUC0-infinity) of BIBR 953 ZW from 0 to infinity
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Area under the plasma concentration-time curve of BIBR 953 ZW (AUCtf -infinity) from tf (last time point when measured plasma concentration) to infinity expressed as % of AUC0-infinity
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Terminal half-life(t1/2 ) of BIBR 953 ZW derived from non-compartmental analysis
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Total mean residence time (MRTtot ) of BIBR 953 ZW
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration
Measured: 24 hours after administration
Volume of distribution (Vz/f ) of BIBR 953 ZW during terminal phase after oral administration
Measured: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Changes from baseline in Pulse rate
Measured: up to day 3
Changes from baseline in Systolic and diastolic blood pressure
Measured: up to day 3
Occurrence of Adverse events
Measured: up to day 3
Changes from baseline in Ecarin Clotting Time (ECT)
Measured: up to day 3
Changes from baseline in thrombin inhibition test time
Measured: up to day 3
Changes from baseline in thrombin time
Measured: up to day 3
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 1998
- Primary completionDec 1998
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
- Double blind
- 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
- NCT02170116
- Sponsor's protocol ID
- 1160.1
- 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
- Pharmacodynamics, Safety and Pharmacokinetics After Single Oral Administration of 10, 30, 100, 200 and 400 mg BIBR 1048 MS as Drinking Solution in Healthy Subjects. An Open Study, Placebo Randomized Double Blind at Each Dose Level.
- ClinicalTrials.gov ID
- NCT02170116
- Acronym / sponsor ID
- 1160.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Dec 1998 (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 objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953 ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048 MS, in healthy male subjects. This was the first administration of this substance to humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 MS dose 1 | Experimental | Drug: BIBR 1048 MS dose 1 |
| BIBR 1048 MS dose 2 | Experimental | Drug: BIBR 1048 MS dose 2 |
| BIBR 1048 MS dose 3 | Experimental | Drug: BIBR 1048 MS dose 3 |
| BIBR 1048 MS dose 4 | Experimental | Drug: BIBR 1048 MS dose 4 |
| BIBR 1048 MS dose 5 | Experimental | Drug: BIBR 1048 MS dose 5 |
| Placebo | Placebo comparator | Drug: Placebo to BIBR 1048 MS |
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 Good Clinical Practice (GCP) and local legislation
- Age >= 18 and <= 45 years
- Broca >= - 20 % and <= + 20 %
Key exclusion criteria (22 listed)
- Any finding 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 or 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 dose 1 | Drug | BIBR 1048 MS dose 1 |
| BIBR 1048 MS dose 2 | Drug | BIBR 1048 MS dose 2 |
| BIBR 1048 MS dose 3 | Drug | BIBR 1048 MS dose 3 |
| BIBR 1048 MS dose 4 | Drug | BIBR 1048 MS dose 4 |
| BIBR 1048 MS dose 5 | Drug | BIBR 1048 MS dose 5 |
| Placebo to BIBR 1048 MS | Drug | Placebo |
Primary outcome
Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR))
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after administration
Changes from baseline in activated partial thromboplastin time (aPTT)
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after administration
15 secondary outcomes
Peak (maximum) plasma concentration (Cmax) of BIBR 953 ZW
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
time to reach the peak plasma concentration (tmax ) of BIBR 953 ZW
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
AUC0-12 h - Area under the plasma concentration-time curve of BIBR 953 ZW from 0 to 12 h
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Area under the plasma concentration-time curve (AUC0-infinity) of BIBR 953 ZW from 0 to infinity
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Area under the plasma concentration-time curve of BIBR 953 ZW (AUCtf -infinity) from tf (last time point when measured plasma concentration) to infinity expressed as % of AUC0-infinity
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Terminal half-life(t1/2 ) of BIBR 953 ZW derived from non-compartmental analysis
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Total mean residence time (MRTtot ) of BIBR 953 ZW
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration
Time frame: 24 hours after administration
Volume of distribution (Vz/f ) of BIBR 953 ZW during terminal phase after oral administration
Time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Changes from baseline in Pulse rate
Time frame: up to day 3
Changes from baseline in Systolic and diastolic blood pressure
Time frame: up to day 3
Occurrence of Adverse events
Time frame: up to day 3
Changes from baseline in Ecarin Clotting Time (ECT)
Time frame: up to day 3
Changes from baseline in thrombin inhibition test time
Time frame: up to day 3
Changes from baseline in thrombin time
Time frame: up to day 3
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 dose 1, BIBR 1048 MS dose 2 and BIBR 1048 MS dose 3 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?
Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR)) (time frame: - 0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after administration). 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.