HealthyPhase 1NCT02265666
Relative Bioavailability, Safety and Tolerability of Two Tablet Formulations of BIIL 284 BS
A Phase 1 study testing BIIL 284 BS Tablet FF, BIIL 284 BS tablet C and standard breakfast in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in healthy male volunteers Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIL 284 BS Tablet FF, BIIL 284 BS tablet C and standard breakfast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Nov 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants are healthy males
- Age range from 21 to 50 years
- Broca-Index: within +- 20% of normal weight
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 16Show fewer
- Intake of a drug with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrollment in the study
- Use of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial)
- Participation in another trial with an investigational drug (<= 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 study days
- Alcohol abuse (> 60g/day)
- Drug abuse
- Blood donation (>= 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within the last week before the study )
- Any laboratory value outside the reference range of clinical relevance
About this study
Official title: Randomised, Open-label, Two-way Crossover Study in Male Healthy Volunteers to Investigate the Relative Bioavailability of BIIL 284 BS 5 mg Tablet FF in Comparison to Tablet C After Ingestion of a Standardised Meal
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in healthy male volunteers
- Conditions
- Healthy
- Being tested
- BIIL 284 BS Tablet FF, BIIL 284 BS tablet C, standard breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIL 284 BS Tablet FFDrug
BIIL 284 BS tablet CDrug
standard breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| BIIL 284 BS Tablet FF | Experimental | Not described Receives: Drug: BIIL 284 BS Tablet FF; Other: standard breakfast |
| BIIL 284 BS tablet C | Active comparator | Not described Receives: Drug: BIIL 284 BS tablet C; Other: standard breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 24 hours after drug administration
Secondary outcomes (10)
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Measured: up to 24 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 24 hours after drug administration
Terminal rate constant in plasma
Measured: up to 24 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 24 hours after drug administration
MRTtot (total mean residence time)
Measured: up to 24 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Measured: up to 24 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Measured: up to 24 hours after drug administration
Number of subjects with adverse events
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital functions
blood pressure, pulse rate, ECG
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 8 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startOct 2001
- Primary completionNov 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT02265666
- Sponsor's protocol ID
- 543.31
- Status last verified
- Oct 2014
- First submitted
- 15 Oct 2014
- Last updated
- 16 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Open-label, Two-way Crossover Study in Male Healthy Volunteers to Investigate the Relative Bioavailability of BIIL 284 BS 5 mg Tablet FF in Comparison to Tablet C After Ingestion of a Standardised Meal
- ClinicalTrials.gov ID
- NCT02265666
- Acronym / sponsor ID
- 543.31
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Nov 2001 (actual)
- First posted
- 16 Oct 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.
The objective of the present study is to investigate the relative bioavailability of BIIL 284 BS Tablet FF in comparison to the tablet C at a dose of 5 mg after a standard breakfast in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIL 284 BS Tablet FF | Experimental | Drug: BIIL 284 BS Tablet FF, Other: standard breakfast |
| BIIL 284 BS tablet C | Active comparator | Drug: BIIL 284 BS tablet C, Other: standard breakfast |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All participants are healthy males
- Age range from 21 to 50 years
- Broca-Index: within +- 20% of normal weight
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study
Key exclusion criteria (16 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- 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 |
|---|---|---|
| BIIL 284 BS Tablet FF | Drug | BIIL 284 BS Tablet FF |
| BIIL 284 BS tablet C | Drug | BIIL 284 BS tablet C |
| standard breakfast | Other | BIIL 284 BS Tablet FF, BIIL 284 BS tablet C |
Primary outcome
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
10 secondary outcomes
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 24 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
Terminal rate constant in plasma
Time frame: up to 24 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 24 hours after drug administration
MRTtot (total mean residence time)
Time frame: up to 24 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 24 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 24 hours after drug administration
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in vital functions
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 8 days after last 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 16 Oct 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 BIIL 284 BS Tablet FF, BIIL 284 BS tablet C and standard 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 16 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 16 Oct 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. 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?
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: up to 24 hours after drug administration). 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 16 Oct 2014.