HealthyPhase 1NCT02211170
Effect of Single Oral Dose BIRB 796 BS on Endotoxin-induced Inflammatory Responses in Healthy Human Subjects
A Phase 1 study testing BIBR 796 BS, low dose, BIBR 796 BS, high dose and Lipopolysaccharide in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses induced by endotoxin in healthy humans Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBR 796 BS, low dose, BIBR 796 BS, high dose and Lipopolysaccharide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Apr 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 35 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 ≤ 35 years
- Broca ≥- 20 % and ≤ + 20%
- Able to communicate well with the investigator and to comply with study requirements
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and EKG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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 within 14 days of enrolment
Show all 20Show 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) (< 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 (< 3 months prior to administration or during trial)
- Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation or loss > 400 ml (< 2 month prior to administration or during the trial)
- Excessive physical activities (< 24 hours prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
- History of any familial bleeding disorder
- Weight > 150 kg
- Prior confirmed or suspected receipt of a monoclonal antibody
About this study
Official title: The Effect of Single Oral Dose BIRB 796 BS (50 and 600 mg) on Endotoxin-induced Inflammatory Responses in Healthy Human Subjects. A Placebo-controlled, Randomised, Parallel, Double-blinded Study.
Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses induced by endotoxin in healthy humans
- Conditions
- Healthy
- Being tested
- BIBR 796 BS, low dose, BIBR 796 BS, high dose, Placebo, Lipopolysaccharide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 796 BS, low doseDrug
BIBR 796 BS, high doseDrug
PlaceboDrug
LipopolysaccharideDrug
Lipopolysaccharide (LPS) for endotoxin challenge
| Study group | Role | What they receive |
|---|---|---|
| BIBR 796 BS, low dose | Experimental | Not described Receives: Drug: BIBR 796 BS, low dose; Drug: Lipopolysaccharide |
| BIBR 796 BS, high dose | Experimental | Not described Receives: Drug: BIBR 796 BS, high dose; Drug: Lipopolysaccharide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Lipopolysaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of tumour necrosis factor alpha (TNFα) concentration
Measured: up to 2 days
Secondary outcomes (20)
Reduction of pro-inflammatory cytokines (IL-6, IL-8, G-CSF)
Measured: up to 2 days
Reduction of anti-inflammatory cytokine and cytokine inhibitors (IL-10, IL-12p40, soluble TNF receptor (sTNFr) type 1, IL-1ra)
Measured: up to 2 days
Reduction of Acute Phase Proteins (C-reactive protein, Haptoglobin)
Measured: up to 2 days
Reduction of Endothelial Activation Markers (von Willebrand Factor, soluble E-selectin)
Measured: up to 2 days
Reduction of Granulocyte Responses (white blood cell (WBC) count with differential, elastase, elastase-á1-antitrypsin complexes)
Measured: up to 2 days
Reduction of flow Cytometry Cell Surface Markers (Mac-1 (macrophage-1 antigen), L-Selectin)
Measured: up to 2 days
Reduction of ex vivo p38 mitogen-activated protein kinase (MAPK) phosphorylation activity
Measured: up to 2 days
Occurence and severity of with chills, nausea, vomiting, abdominal pain, backache, headache, myalgia, fever
Measured: up to 2 days
Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure, temperature)
Measured: up to 14 days
Number of patients with abnormal changes in laboratory parameters
Measured: up to 14 days
Number of patients with adverse events
Measured: up to 14 days
Assessment of Global Clinical Tolerability on a 4-point scale
Measured: after 14 days
Maximum plasma concentration (Cmax)
Measured: up to 27 hours after drug administration
Time at which Cmax occurred (tmax)
Measured: up to 27 hours after drug administration
Elimination half life (t1/2),
Measured: up to 27 hours after drug administration
Area under the plasma concentration-time curve for different time points(AUC)
Measured: up to 27 hours after drug administration
Apparent clearance (CL/F)
Measured: up to 27 hours after drug administration
Elimination rate constant (λz)
Measured: up to 27 hours after drug administration
Mean residence time (MRT)
Measured: up to 27 hours after drug administration
Apparent volume of distribution (Vz/F)
Measured: up to 27 hours after drug administration
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 startFeb 2000
- Primary completionApr 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
- NCT02211170
- Sponsor's protocol ID
- 1175.4
- 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
- The Effect of Single Oral Dose BIRB 796 BS (50 and 600 mg) on Endotoxin-induced Inflammatory Responses in Healthy Human Subjects. A Placebo-controlled, Randomised, Parallel, Double-blinded Study.
- ClinicalTrials.gov ID
- NCT02211170
- Acronym / sponsor ID
- 1175.4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Apr 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 determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses induced by endotoxin in healthy humans
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIBR 796 BS, low dose | Experimental | Drug: BIBR 796 BS, low dose, Drug: Lipopolysaccharide |
| BIBR 796 BS, high dose | Experimental | Drug: BIBR 796 BS, high dose, Drug: Lipopolysaccharide |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Lipopolysaccharide |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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 ≤ 35 years
- Broca ≥- 20 % and ≤ + 20%
- Able to communicate well with the investigator and to comply with study requirements
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and EKG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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, low dose | Drug | BIBR 796 BS, low dose |
| BIBR 796 BS, high dose | Drug | BIBR 796 BS, high dose |
| Placebo | Drug | Placebo |
| LipopolysaccharideLipopolysaccharide (LPS) for endotoxin challenge | Drug | BIBR 796 BS, high dose, BIBR 796 BS, low dose, Placebo |
Primary outcome
Reduction of tumour necrosis factor alpha (TNFα) concentration
Time frame: up to 2 days
20 secondary outcomes
Reduction of pro-inflammatory cytokines (IL-6, IL-8, G-CSF)
Time frame: up to 2 days
Reduction of anti-inflammatory cytokine and cytokine inhibitors (IL-10, IL-12p40, soluble TNF receptor (sTNFr) type 1, IL-1ra)
Time frame: up to 2 days
Reduction of Acute Phase Proteins (C-reactive protein, Haptoglobin)
Time frame: up to 2 days
Reduction of Endothelial Activation Markers (von Willebrand Factor, soluble E-selectin)
Time frame: up to 2 days
Reduction of Granulocyte Responses (white blood cell (WBC) count with differential, elastase, elastase-á1-antitrypsin complexes)
Time frame: up to 2 days
Reduction of flow Cytometry Cell Surface Markers (Mac-1 (macrophage-1 antigen), L-Selectin)
Time frame: up to 2 days
Reduction of ex vivo p38 mitogen-activated protein kinase (MAPK) phosphorylation activity
Time frame: up to 2 days
Occurence and severity of with chills, nausea, vomiting, abdominal pain, backache, headache, myalgia, fever
Time frame: up to 2 days
Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure, temperature)
Time frame: up to 14 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 14 days
Number of patients with adverse events
Time frame: up to 14 days
Assessment of Global Clinical Tolerability on a 4-point scale
Time frame: after 14 days
Maximum plasma concentration (Cmax)
Time frame: up to 27 hours after drug administration
Time at which Cmax occurred (tmax)
Time frame: up to 27 hours after drug administration
Elimination half life (t1/2),
Time frame: up to 27 hours after drug administration
Area under the plasma concentration-time curve for different time points(AUC)
Time frame: up to 27 hours after drug administration
Apparent clearance (CL/F)
Time frame: up to 27 hours after drug administration
Elimination rate constant (λz)
Time frame: up to 27 hours after drug administration
Mean residence time (MRT)
Time frame: up to 27 hours after drug administration
Apparent volume of distribution (Vz/F)
Time frame: up to 27 hours after 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 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, low dose, BIBR 796 BS, high dose and Lipopolysaccharide 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 20 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?
Reduction of tumour necrosis factor alpha (TNFα) concentration (time frame: up to 2 days). 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.