HealthyPhase 1NCT02211157
Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to Healthy Human Subjects
A Phase 1 study testing BIBR 796 BS and high fat breakfast in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level 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 796 BS and high fat breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Mar 2000to Jul 2000
- 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 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
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
Show all 19Show fewer
- 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 1 month prior to administration or during the trial)
- 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)
- Inability to refrain from smoking on study days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation > 400 ml 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 reference range of clinical relevance including, but not limited to total white cell count ≥ 10 x 10**9/L, C-reactive protein ≥ 4.5 mg/L, Gamma-Glutamyl Transferase ≥ 40 U/L, any hemoglobin or > 15 mg/dl protein or urine dipstick, abnormal Multitest® assessment of cellular immunity
- History of any familial bleeding disorder
- Inability to comply with dietary regimen of study centre
About this study
Official title: Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets (20, 30, 150, 300, and 600 mg) Administered Orally to Healthy Human Subjects Once Daily for 7 Days. A Placebo Controlled, Randomised, Double Blinded Study
Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level
- Conditions
- Healthy
- Being tested
- BIBR 796 BS, Placebo, high fat breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 796 BSDrug
PlaceboDrug
high fat breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| BIBR 796 BS, fasted | Experimental | dose escalation Receives: Drug: BIBR 796 BS |
| BIBR 796 BS, fed | Experimental | 50 mg BIRB 796 BS (food effect) Receives: Drug: BIBR 796 BS; Other: high fat breakfast |
| 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 relevant changes in laboratory parameters
Measured: up to day 16
Number of patients with abnormal findings in electrocardiogram (ECG)
Measured: up to day 16
Number of patients with adverse events
Measured: up to 30 days
Assessment of tolerability on a 4-point scale
Measured: day 16
Number of patients with clinically relevant changes in vital signs
Measured: up to 16 days
Secondary outcomes (12)
Maximum plasma concentration (Cmax) for several time points
Measured: up to day 9
Area under the plasma concentration-time curve (AUC) for several time points
Measured: up to day 9
Time to maximum concentration (tmax)
Measured: up to day 9
Elimination rate constant (λz)
Measured: up to day 9
Terminal half-life (t1/2)
Measured: up to day 9
Mean residence time (MRT)
Measured: up to day 9
Apparent clearance (CL/f)
Measured: up to day 9
Apparent volume of distribution (Vz/F)
Measured: up to day 9
Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with formyl-methionyl-leucyl-phenylalanine (fMLP)
Change in the Mac-1 / L-selectin ratio
Measured: up to day 9
Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with tumour necrosis factor (TNF) α
Change in the Mac-1 / L-selectin ratio
Measured: up to day 9
Assessment of TNFα production by ex vivo stimulation of whole blood with endotoxin
Measured: up to day 9
Changes in cellular immune response measured by Multitest®
Measured: Day 8
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 2000
- Primary completionJul 2000
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
- 24 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
- NCT02211157
- Sponsor's protocol ID
- 1175.3
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets (20, 30, 150, 300, and 600 mg) Administered Orally to Healthy Human Subjects Once Daily for 7 Days. A Placebo Controlled, Randomised, Double Blinded Study
- ClinicalTrials.gov ID
- NCT02211157
- Acronym / sponsor ID
- 1175.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Jul 2000 (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 safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIBR 796 BS, fasted | Experimental | Drug: BIBR 796 BSdose escalation |
| BIBR 796 BS, fed | Experimental | Drug: BIBR 796 BS, Other: high fat breakfast50 mg BIRB 796 BS (food effect) |
| Placebo | Placebo comparator | Drug: 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 and local legislation
- Age ≥ 18 and ≤ 45 years
- Broca ≥ - 20% and ≤ + 20%
Key exclusion criteria (19 listed)
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- History of orthostatic hypotension, fainting spells and blackouts
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 | BIBR 796 BS, fasted, BIBR 796 BS, fed |
| Placebo | Drug | Placebo |
| high fat breakfast | Other | BIBR 796 BS, fed |
Primary outcome
Number of patients with clinically relevant changes in laboratory parameters
Time frame: up to day 16
Number of patients with abnormal findings in electrocardiogram (ECG)
Time frame: up to day 16
Number of patients with adverse events
Time frame: up to 30 days
Assessment of tolerability on a 4-point scale
Time frame: day 16
Number of patients with clinically relevant changes in vital signs
Time frame: up to 16 days
12 secondary outcomes
Maximum plasma concentration (Cmax) for several time points
Time frame: up to day 9
Area under the plasma concentration-time curve (AUC) for several time points
Time frame: up to day 9
Time to maximum concentration (tmax)
Time frame: up to day 9
Elimination rate constant (λz)
Time frame: up to day 9
Terminal half-life (t1/2)
Time frame: up to day 9
Mean residence time (MRT)
Time frame: up to day 9
Apparent clearance (CL/f)
Time frame: up to day 9
Apparent volume of distribution (Vz/F)
Time frame: up to day 9
Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with formyl-methionyl-leucyl-phenylalanine (fMLP)
Time frame: up to day 9
Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with tumour necrosis factor (TNF) α
Time frame: up to day 9
Assessment of TNFα production by ex vivo stimulation of whole blood with endotoxin
Time frame: up to day 9
Changes in cellular immune response measured by Multitest®
Time frame: Day 8
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 8 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 and high fat breakfast 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 19 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 8 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 relevant changes in laboratory parameters (time frame: up to day 16). 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 8 Aug 2014.