HealthyPhase 1NCT02214940
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple, Rising Oral Doses of BI 11634 Oral Solution in Healthy Male Volunteers
A Phase 1 study testing BI 11634 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect of BI 11634 on coagulation parameters after multiple-dose administration (no primary endpoint in a statistical sense defined) Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 11634
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Sep 2007
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, clinical laboratory tests
- Age ≥18 and ≤50 years
- Haemoglobin within the normal ranges
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation
Who cannot join
- Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder or acute and chronic blood coagulation defect, for the subject itself or any person of his family as far as known
- History of gastric ulcera and cholecystectomy
- Occult blood in feces
- Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
Show all 26Show fewer
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Relevant chronic or acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (more than 40 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Vulnerable subjects (e.g. persons kept in detention)
- The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Subjects with a history within the past six weeks of closed-head or torso trauma or deceleration injury such as an automobile accident or fall from a significant height
- Inability to comply with dietary regimen of the study centre
- Inability to understand the protocol requirements, instructions and study-related restrictions; the nature, scope and possible consequences of the study
- Subjects (including those who have had a vasectomy) who do not agree to use two methods of contraception, including barrier contraception (latex condoms with spermicide plus intrauterine device) when engaging in sexual activity with women of child bearing potential during the study and for 60 days after completion of the study
About this study
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple, Rising Oral Doses of 2.5 mg, 5 mg, 7.5 mg, and 10 mg BI 11634 Oral Solution Administered t.i.d. for 5 Days to Healthy Male Volunteers; Randomised, Doubleblind, Placebo-controlled at Each Dose Level
First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect of BI 11634 on coagulation parameters after multiple-dose administration (no primary endpoint in a statistical sense defined)
- Conditions
- Healthy
- Being tested
- BI 11634, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 11634Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 11634 | Experimental | multiple rising dose Receives: Drug: BI 11634 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: up to 10 days after last drug administration
Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate)
Measured: up to 10 days after last drug administration
Number of subjects with clinically significant findings in ECG
Measured: up to 10 days after last drug administration
Number of subjects with clinically significant findings laboratory tests
Measured: up to 10 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: up to 10 days after last drug administration
Secondary outcomes (28)
Cmax (maximum measured concentration of analyte in plasma)
Measured: up to 144 hours after first drug administration
tmax (time from dosing to maximum measured concentration)
Measured: up to 144 hours after first drug administration
AUCτ,n (area under the concentration-time curve of analyte in plasma over a uniform dosing interval τ after administration of the n-th dose)
Measured: up to 144 hours after first drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: up to 144 hours after first drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: up to 144 hours after first drug administration
CLR,t1-t2 (renal clearance of analyte from the time point t1 until the time point t2)
Measured: up to 144 hours after first drug administration
Cmin,ss (minimum measured concentration of analyte in plasma at steady state over a uniform dosing interval τ)
Measured: up to 144 hours after first drug administration
Cpre,ss (predose concentration of analyte in plasma at steady state immediately before administration of the next dose)
Measured: up to 144 hours after first drug administration
λz,ss (terminal rate constant in plasma at steady state)
Measured: up to 144 hours after first drug administration
t1/2,ss (terminal half-life of analyte in plasma at steady state)
Measured: up to 144 hours after first drug administration
MRTpo,ss (mean residence time of analyte in the body after multiple oral administrations at steady state)
Measured: up to 144 hours after first drug administration
CL/F,ss (apparent clearance of analyte in the plasma at steady state following extravascular multiple dose administration)
Measured: up to 144 hours after first drug administration
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Measured: up to 144 hours after first drug administration
PTF (peak-trough fluctuation)
Measured: up to 144 hours after first drug administration
Cavg (average concentration of analyte in plasma at steady state)
Measured: up to 144 hours after first drug administration
RA,Cmax (Accumulation ratio of analyte in plasma based on Cmax)
Measured: up to 144 hours after first drug administration
RA,AUC (Accumulation ratio of analyte in plasma based on AUC)
Measured: up to 144 hours after first drug administration
Cpre,N (predose concentration of analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered )
Measured: up to 144 hours after first drug administration
Activated partial thromboplastin time (aPTT) ratios between groups
Measured: up to 144 hours after first drug administration
Maximum aPTT prolongation
Measured: up to 144 hours after first drug administration
Maximum international normalized ratio (INR)
Measured: up to 144 hours after first drug administration
% inhibition of endogenous Factor Xa
by Russel's Viper Venom test (RVV)
Measured: up to 144 hours after first drug administration
Maximum prolongation of blood coagulation time
by HepTest® (Haemachem Inc.)
Measured: up to 144 hours after first drug administration
Percent inhibition of FXa
by COAMATIC© Heparin test (Chromogenix)
Measured: up to 144 hours after first drug administration
Percent inhibition of thrombin generation by BI 11634
Measured: up to 144 hours after first drug administration
Percent peak inhibition of thrombin generation
Measured: up to 144 hours after first drug administration
Time to maximum inhibition of thrombin generation BI 11634
Measured: up to 144 hours after first drug administration
Percent prolongation of lag time
Measured: up to 144 hours after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJun 2007
- Primary completionSep 2007
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
- 48 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
- NCT02214940
- Sponsor's protocol ID
- 1234.2
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple, Rising Oral Doses of 2.5 mg, 5 mg, 7.5 mg, and 10 mg BI 11634 Oral Solution Administered t.i.d. for 5 Days to Healthy Male Volunteers; Randomised, Doubleblind, Placebo-controlled at Each Dose Level
- ClinicalTrials.gov ID
- NCT02214940
- Acronym / sponsor ID
- 1234.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Sep 2007 (actual)
- First posted
- 13 Aug 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.
First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect of BI 11634 on coagulation parameters after multiple-dose administration (no primary endpoint in a statistical sense defined)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 11634 | Experimental | Drug: BI 11634multiple rising dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Caucasian males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, clinical laboratory tests
- Age ≥18 and ≤50 years
- Haemoglobin within the normal ranges
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation
Key exclusion criteria (26 listed)
- Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder or acute and chronic blood coagulation defect, for the subject itself or any person of his family as far as known
- History of gastric ulcera and cholecystectomy
- Occult blood in feces
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 |
|---|---|---|
| BI 11634 | Drug | BI 11634 |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: up to 10 days after last drug administration
Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate)
Time frame: up to 10 days after last drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 10 days after last drug administration
Number of subjects with clinically significant findings laboratory tests
Time frame: up to 10 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 10 days after last drug administration
28 secondary outcomes
Cmax (maximum measured concentration of analyte in plasma)
Time frame: up to 144 hours after first drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: up to 144 hours after first drug administration
AUCτ,n (area under the concentration-time curve of analyte in plasma over a uniform dosing interval τ after administration of the n-th dose)
Time frame: up to 144 hours after first drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: up to 144 hours after first drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 144 hours after first drug administration
CLR,t1-t2 (renal clearance of analyte from the time point t1 until the time point t2)
Time frame: up to 144 hours after first drug administration
Cmin,ss (minimum measured concentration of analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 144 hours after first drug administration
Cpre,ss (predose concentration of analyte in plasma at steady state immediately before administration of the next dose)
Time frame: up to 144 hours after first drug administration
λz,ss (terminal rate constant in plasma at steady state)
Time frame: up to 144 hours after first drug administration
t1/2,ss (terminal half-life of analyte in plasma at steady state)
Time frame: up to 144 hours after first drug administration
MRTpo,ss (mean residence time of analyte in the body after multiple oral administrations at steady state)
Time frame: up to 144 hours after first drug administration
CL/F,ss (apparent clearance of analyte in the plasma at steady state following extravascular multiple dose administration)
Time frame: up to 144 hours after first drug administration
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: up to 144 hours after first drug administration
PTF (peak-trough fluctuation)
Time frame: up to 144 hours after first drug administration
Cavg (average concentration of analyte in plasma at steady state)
Time frame: up to 144 hours after first drug administration
RA,Cmax (Accumulation ratio of analyte in plasma based on Cmax)
Time frame: up to 144 hours after first drug administration
RA,AUC (Accumulation ratio of analyte in plasma based on AUC)
Time frame: up to 144 hours after first drug administration
Cpre,N (predose concentration of analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered )
Time frame: up to 144 hours after first drug administration
Activated partial thromboplastin time (aPTT) ratios between groups
Time frame: up to 144 hours after first drug administration
Maximum aPTT prolongation
Time frame: up to 144 hours after first drug administration
Maximum international normalized ratio (INR)
Time frame: up to 144 hours after first drug administration
% inhibition of endogenous Factor Xa
Time frame: up to 144 hours after first drug administration
Maximum prolongation of blood coagulation time
Time frame: up to 144 hours after first drug administration
Percent inhibition of FXa
Time frame: up to 144 hours after first drug administration
Percent inhibition of thrombin generation by BI 11634
Time frame: up to 144 hours after first drug administration
Percent peak inhibition of thrombin generation
Time frame: up to 144 hours after first drug administration
Time to maximum inhibition of thrombin generation BI 11634
Time frame: up to 144 hours after first drug administration
Percent prolongation of lag time
Time frame: up to 144 hours after first drug administration
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 13 Aug 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 BI 11634 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 5 inclusion and 26 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 13 Aug 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?
Number of subjects with adverse events (time frame: up to 10 days after last drug administration). The study lists 5 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 13 Aug 2014.