HealthyPhase 1NCT02182037
Safety, Pharmacodynamics, and Pharmacokinetics of BIBT 1011 BS in Healthy Subjects
A Phase 1 study testing Single rising doses of BIBT 1011 BS in people with Healthy, run by Boehringer Ingelheim.
Trial summary
A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011 BS, 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?
- Single rising doses of BIBT 1011 BS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Sep 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 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
- Body Mass Index ≥ 18.5 and ≤ 29.9 kg/m2
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, immunological, 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)
- 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 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: Safety, Pharmacodynamics, and Pharmacokinetics After Single Oral Administration of 1, 5, 10, 30, 100, 200 and 400 mg BIBT 1011 BS as Drinking Solution in Healthy Subjects. An Open, Placebo-controlled, Randomised Study, Double Blind at Each Dose Level
A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011 BS, on coagulation parameters.
- Conditions
- Healthy
- Being tested
- Single rising doses of BIBT 1011 BS, BIBT 1011 BS placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single rising doses of BIBT 1011 BSDrug
BIBT 1011 BS placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBT 1011 BS | Experimental | Not described Receives: Drug: Single rising doses of BIBT 1011 BS |
| BIBT 1011 BS placebo | Placebo comparator | Not described Receives: Drug: BIBT 1011 BS placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of activated partial thromboplastin time (aPTT)
Measured: Pre-dose, up to 48 hours after start of treatment
Determination of international normalized ration (INR)
Measured: Pre-dose, up to 48 hours after start of treatment
Secondary outcomes (13)
Determination of thrombin time (TT)
Measured: Pre-dose, up to 48 hours after start of treatment
Determination of ecarin clotting time (ECT)
Measured: Pre-dose, up to 48 hours after start of treatment
Assessment of plasma concentration time profiles of BIBT 986 BS
Measured: Pre-dose, up to 48 hours after start of treatment
Maximum concentration of BIBT 986 BS in plasma (Cmax)
Measured: Pre-dose, up to 48 hours after start of treatment
Area under the concentration time curve for BIBT 986 BS (AUC)
Measured: Pre-dose, up to 48 hours after start of treatment
Time from dosing to when the plasma concentration reaches Cmax after a single extravascular dose (tmax)
Measured: Pre-dose, up to 48 hours after start of treatment
Total mean time of residence of BIBT 986 BS- molecules in the body (MRTtot)
Measured: Pre-dose, up to 48 hours after start of treatment
Apparent volume of distribution of the analytes during the terminal phase (Vz/f)
Measured: Pre-dose, up to 48 hours after start of treatment
Terminal elimination half life of BIBT 986 BS in plasma (t1/2)
Measured: Pre-dose, up to 48 hours after start of treatment
Amount excreted over the 24 hour sampling period (Ae0-24)
Measured: Pre-dose, up to 24 hours after start of treatment
Total clearance after oral administration (CLtot/F)
Measured: Pre-dose, up to 48 hours after start of treatment
Number of patients with adverse events
Measured: Up to 17 days
Assessment of BIBT 986 BS plasma concentration- aPTT relationship
Measured: Pre-dose, up to 48 hours after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startAug 2001
- Primary completionSep 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 56 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
- NCT02182037
- Sponsor's protocol ID
- 1193.1
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Pharmacodynamics, and Pharmacokinetics After Single Oral Administration of 1, 5, 10, 30, 100, 200 and 400 mg BIBT 1011 BS as Drinking Solution in Healthy Subjects. An Open, Placebo-controlled, Randomised Study, Double Blind at Each Dose Level
- ClinicalTrials.gov ID
- NCT02182037
- Acronym / sponsor ID
- 1193.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Sep 2001 (actual)
- First posted
- 8 Jul 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.
A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011 BS, on coagulation parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBT 1011 BS | Experimental | Drug: Single rising doses of BIBT 1011 BS |
| BIBT 1011 BS placebo | Placebo comparator | Drug: BIBT 1011 BS 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 good clinical practice (GCP) and local legislation
- Age ≥ 18 and ≤ 45 years
- Body Mass Index ≥ 18.5 and ≤ 29.9 kg/m2
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, immunological, 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 |
|---|---|---|
| Single rising doses of BIBT 1011 BS | Drug | BIBT 1011 BS |
| BIBT 1011 BS placebo | Drug | BIBT 1011 BS placebo |
Primary outcome
Determination of activated partial thromboplastin time (aPTT)
Time frame: Pre-dose, up to 48 hours after start of treatment
Determination of international normalized ration (INR)
Time frame: Pre-dose, up to 48 hours after start of treatment
13 secondary outcomes
Determination of thrombin time (TT)
Time frame: Pre-dose, up to 48 hours after start of treatment
Determination of ecarin clotting time (ECT)
Time frame: Pre-dose, up to 48 hours after start of treatment
Assessment of plasma concentration time profiles of BIBT 986 BS
Time frame: Pre-dose, up to 48 hours after start of treatment
Maximum concentration of BIBT 986 BS in plasma (Cmax)
Time frame: Pre-dose, up to 48 hours after start of treatment
Area under the concentration time curve for BIBT 986 BS (AUC)
Time frame: Pre-dose, up to 48 hours after start of treatment
Time from dosing to when the plasma concentration reaches Cmax after a single extravascular dose (tmax)
Time frame: Pre-dose, up to 48 hours after start of treatment
Total mean time of residence of BIBT 986 BS- molecules in the body (MRTtot)
Time frame: Pre-dose, up to 48 hours after start of treatment
Apparent volume of distribution of the analytes during the terminal phase (Vz/f)
Time frame: Pre-dose, up to 48 hours after start of treatment
Terminal elimination half life of BIBT 986 BS in plasma (t1/2)
Time frame: Pre-dose, up to 48 hours after start of treatment
Amount excreted over the 24 hour sampling period (Ae0-24)
Time frame: Pre-dose, up to 24 hours after start of treatment
Total clearance after oral administration (CLtot/F)
Time frame: Pre-dose, up to 48 hours after start of treatment
Number of patients with adverse events
Time frame: Up to 17 days
Assessment of BIBT 986 BS plasma concentration- aPTT relationship
Time frame: Pre-dose, up to 48 hours after start of 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 14 Jul 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 Single rising doses of BIBT 1011 BS 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 14 Jul 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?
Determination of activated partial thromboplastin time (aPTT) (time frame: Pre-dose, up to 48 hours after start of 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 14 Jul 2014.