HealthyPhase 1NCT02265302
Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males
A Phase 1 study testing BIIL 284 oral solution and BIIL 284 wetability improved formulation (WIF) tablets in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food… 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 oral solution and BIIL 284 wetability improved formulation (WIF) tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Jun 1998to Dec 1998
- 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
- Healthy male subjects as determined by results of screening
- Age ≥ 21 and ≤ 50 years
- Broca ≥ - 20% and ≤ + 20%
- Signed written informed consent in accordance with Good Clinical Practice and local legislation
Who cannot join
- Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values
- Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- Known 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 15Show 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 enrolment in the study
- Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study
- Participation in another study with an investigational drug within the last two months preceding this study
- Smokers (> 5 cigarettes or 2 cigars or 2 pipes/day)
- Volunteer who is not able to refrain from smoking on study days
- Alcohol abuse (more than 60 g of alcohol per day)
- Drug abuse
- Excessive physical activities (e.g. competitive sports) within the last week before the study
- Blood donation within the last 4 weeks (≥ 100 ml)
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS (Dose Range: 0.025 mg - 75 mg PSE Solution, 25 mg, 75 mg, 250 mg and 750 mg WIF Tablets) in Healthy Male Volunteers as Well as Food Effects at 75 mg (WIF Tablet)
Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers
- Conditions
- Healthy
- Being tested
- BIIL 284 oral solution, BIIL 284 wetability improved formulation (WIF) tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIL 284 oral solutionDrug
BIIL 284 wetability improved formulation (WIF) tabletsDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIL 284 BS oral solution | Experimental | Not described Receives: Drug: BIIL 284 oral solution |
| BIIL 284 BS WIF tablets | Experimental | Not described Receives: Drug: BIIL 284 wetability improved formulation (WIF) tablets |
| 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 clinically relevant changes in vital signs
Measured: up to 8 days after drug administration
Number of subjects with clinically relevant changes in electrocardiogram
Measured: up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters
Measured: up to 8 days after drug administration
Number of subjects with adverse events
Measured: up to 8 days after drug administration
Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)
Measured: up to 72 hours after drug administration
Secondary outcomes (9)
Changes in white blood cell count
determined by flow cytometer
Measured: up to 48 hours after drug administration
Changes in differential blood cell count
determined by flow cytometer
Measured: up to 48 hours after drug administration
Maximum plasma concentration (Cmax)
Measured: up to 72 hours after drug administration
Time to reach maximum plasma concentration (tmax)
Measured: up to 72 hours after drug administration
Area under the plasma concentration-time curve (AUC) for several time intervals
Measured: up to 72 hours after drug administration
Terminal half-life (t1/2)
Measured: up to 72 hours after drug administration
Total mean residence time (MRTtot)
Measured: up to 72 hours after drug administration
Total clearance after oral administration (CLtot/f)
Measured: up to 72 hours after drug administration
Volume of distribution during terminal phase after oral administration (Vz/f)
Measured: up to 72 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 posted15 Oct 2014 (estimated)
- Study startJun 1998
- Primary completionDec 1998
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
- 95 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
- NCT02265302
- Sponsor's protocol ID
- 543.1
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS (Dose Range: 0.025 mg - 75 mg PSE Solution, 25 mg, 75 mg, 250 mg and 750 mg WIF Tablets) in Healthy Male Volunteers as Well as Food Effects at 75 mg (WIF Tablet)
- ClinicalTrials.gov ID
- NCT02265302
- Acronym / sponsor ID
- 543.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 15 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.
Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIIL 284 BS oral solution | Experimental | Drug: BIIL 284 oral solution |
| BIIL 284 BS WIF tablets | Experimental | Drug: BIIL 284 wetability improved formulation (WIF) tablets |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects as determined by results of screening
- Age ≥ 21 and ≤ 50 years
- Broca ≥ - 20% and ≤ + 20%
- Signed written informed consent in accordance with Good Clinical Practice and local legislation
Key exclusion criteria (15 listed)
- Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values
- Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- Known 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 oral solution | Drug | BIIL 284 BS oral solution |
| BIIL 284 wetability improved formulation (WIF) tablets | Drug | BIIL 284 BS WIF tablets |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with clinically relevant changes in vital signs
Time frame: up to 8 days after drug administration
Number of subjects with clinically relevant changes in electrocardiogram
Time frame: up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters
Time frame: up to 8 days after drug administration
Number of subjects with adverse events
Time frame: up to 8 days after drug administration
Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)
Time frame: up to 72 hours after drug administration
9 secondary outcomes
Changes in white blood cell count
Time frame: up to 48 hours after drug administration
Changes in differential blood cell count
Time frame: up to 48 hours after drug administration
Maximum plasma concentration (Cmax)
Time frame: up to 72 hours after drug administration
Time to reach maximum plasma concentration (tmax)
Time frame: up to 72 hours after drug administration
Area under the plasma concentration-time curve (AUC) for several time intervals
Time frame: up to 72 hours after drug administration
Terminal half-life (t1/2)
Time frame: up to 72 hours after drug administration
Total mean residence time (MRTtot)
Time frame: up to 72 hours after drug administration
Total clearance after oral administration (CLtot/f)
Time frame: up to 72 hours after drug administration
Volume of distribution during terminal phase after oral administration (Vz/f)
Time frame: up to 72 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 15 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 oral solution and BIIL 284 wetability improved formulation (WIF) tablets 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 15 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 15 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. 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 clinically relevant changes in vital signs (time frame: up to 8 days after 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 15 Oct 2014.