HealthyPhase 1NCT02211144
Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally to Healthy Human Subjects
A Phase 1 study testing BIBR 796 BS in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBR 796 BS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Nov 2002
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Female subjects who were not lactating and not of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone (FSH) with low estradiol while on no estrogen supplementation). Females were to use barrier contraception (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study. Women must have had negative blood pregnancy tests
- Age ≥ 18 and ≤ 60 years
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Able to communicate well with the investigator and to comply with study requirements
- Laboratory values within a clinically defined reference range
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 23Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
- Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
- Use of any drugs, which might influence the results of the trial, (< 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (< 1 months prior to administration (at least 10 times the relevant elimination half-life) or during the trial)
- Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
- Smoker
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco < 5 days prior to administration of study drug
- Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)
- Excessive physical activities (< 5 days prior to administration or during the trial)
- Following specific laboratory findings: white blood cell count, C-reactive protein, gamma-glutamyl-transferase, aspartate transaminase, alanine transaminase, or glutamate dehydrogenase above the normal range; any erythrocytes or > 15 mg/dl protein on urine dipstick if not menstruating
- Any EKG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms or QRS interval > 110 ms
- History of any familial bleeding disorder
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
About this study
Official title: Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally (Total Daily Dose 90, 120, 150 or 180 mg) to Healthy Human Subjects for 14 Days. A Placebo-controlled, Dose Escalation Study Double Blinded at Each Dose Level
Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels
- Conditions
- Healthy
- Being tested
- BIBR 796 BS, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 796 BSDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIRB 796 BS | Experimental | in escalating doses Receives: Drug: BIBR 796 BS; Drug: Placebo |
| 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 patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure)
Measured: up to day 21
Number of patients with clinically relevant changes in laboratory parameters
Measured: up to day 21
Number of patients with clinical relevant findings in electrocardiogram (ECG)
Measured: up to day 21
Number of patients with adverse events
Measured: up to 35 days
Clinical assessment of tolerability on a 4-point scale
Measured: day 21
Secondary outcomes (10)
Maximum observed plasma concentration during steady state dosing interval (Cmax,ss)
Measured: up to day 16
area under the plasma concentration versus time curve at different time points (AUC)
Measured: up to day 16
Time to the maximum plasma concentration at steady state (tmax,ss)
Measured: up to day 16
Elimination half-life (t1/2)
Measured: up to day 16
Terminal elimination rate constant (λz)
Measured: up to day 16
Average steady state plasma concentration (Css)
Measured: up to day 16
Mean residence time (MRT)
Measured: up to day 16
Total apparent oral clearance of drug from plasma after oral administration (CL/F )
Measured: up to day 16
Apparent volume of distribution based on terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Measured: up to day 16
Morning trough plasma concentration prior day 14
Measured: on day 2, 3, 5, 7, 9, 13 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startMar 2002
- Primary completionNov 2002
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
- 120 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
- NCT02211144
- Sponsor's protocol ID
- 1175.21
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally (Total Daily Dose 90, 120, 150 or 180 mg) to Healthy Human Subjects for 14 Days. A Placebo-controlled, Dose Escalation Study Double Blinded at Each Dose Level
- ClinicalTrials.gov ID
- NCT02211144
- Acronym / sponsor ID
- 1175.21
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Nov 2002 (actual)
- First posted
- 7 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.
Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIRB 796 BS | Experimental | Drug: BIBR 796 BS, Drug: Placeboin escalating doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Female subjects who were not lactating and not of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone (FSH) with low estradiol while on no estrogen supplementation). Females were to use barrier contraception (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study. Women must have had negative blood pregnancy tests
- Age ≥ 18 and ≤ 60 years
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
Key exclusion criteria (23 listed)
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
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 796 BS | Drug | BIRB 796 BS |
| Placebo | Drug | BIRB 796 BS, Placebo |
Primary outcome
Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure)
Time frame: up to day 21
Number of patients with clinically relevant changes in laboratory parameters
Time frame: up to day 21
Number of patients with clinical relevant findings in electrocardiogram (ECG)
Time frame: up to day 21
Number of patients with adverse events
Time frame: up to 35 days
Clinical assessment of tolerability on a 4-point scale
Time frame: day 21
10 secondary outcomes
Maximum observed plasma concentration during steady state dosing interval (Cmax,ss)
Time frame: up to day 16
area under the plasma concentration versus time curve at different time points (AUC)
Time frame: up to day 16
Time to the maximum plasma concentration at steady state (tmax,ss)
Time frame: up to day 16
Elimination half-life (t1/2)
Time frame: up to day 16
Terminal elimination rate constant (λz)
Time frame: up to day 16
Average steady state plasma concentration (Css)
Time frame: up to day 16
Mean residence time (MRT)
Time frame: up to day 16
Total apparent oral clearance of drug from plasma after oral administration (CL/F )
Time frame: up to day 16
Apparent volume of distribution based on terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Time frame: up to day 16
Morning trough plasma concentration prior day 14
Time frame: on day 2, 3, 5, 7, 9, 13 and 14
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 7 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 BIBR 796 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 7 inclusion and 23 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 7 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 patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure) (time frame: up to day 21). 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 7 Aug 2014.