HealthyPhase 1NCT02273414
Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Doses of BIIL 284 BS in Healthy Male Volunteers
A Phase 1 study testing BIIL 284 BS - rising dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the present study is to obtain information about the safety and tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary pharmacokinetic data concerning steady state and… 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 - rising dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jul 1999to Sep 1999
- 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 their 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
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- Volunteers with history of orthostatic hypotension, fainting spells or blackouts
- Volunteers with chronic or relevant acute infections
- Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 15Show fewer
- Volunteers with eosinophilia > 7 %
- Volunteers who have taken 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
- Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
- Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
- Volunteers who smoke
- Volunteers who drink more than 60g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
- Volunteers who have donated blood 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 Repeated Oral Doses (9 Days Dosing) of BIIL 284 BS (Doses: 25 mg, 150 mg, 250 mg as WIF Tablets) in Healthy Male Volunteers
The objective of the present study is to obtain information about the safety and tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary pharmacokinetic data concerning steady state and accumulation factor
- Conditions
- Healthy
- Being tested
- BIIL 284 BS - rising dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIL 284 BS - rising doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIL 284 BS - rising dose | Experimental | Not described Receives: Drug: BIIL 284 BS - rising dose |
| 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 adverse events
Measured: up to 8 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant changes in vital signs
Blood pressure, Pulse Rate, Respiratory Rate
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant changes in 12-lead electrocardiogram
Measured: up to 8 days after last drug administration
Secondary outcomes (11)
AUC0-24h (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
Measured: up to 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 80 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 80 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 80 hours after drug administration
MRTtot (Total mean residence time)
Measured: up to 80 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Measured: up to 80 hours after drug administration
CLtot/F (Total clearance after oral administration)
Measured: up to 80 hours after drug administration
Ae0-24h (Amount of analyte that is eliminated in urine from 0 to 24 hours)
Measured: up to 24 hours after drug administration
AUCss (Area under the plasma concentration-time curve at steady state)
Measured: up to 80 hours after drug administration
Cpre,ss (Predose concentration of the analyte in plasma at steady state)
Measured: up to 80 hours after drug administration
Changes in Leucotriene B4 (LTB4) induced Mac-1 expression
Measured: up to 24 hours after last treatment on day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJul 1999
- Primary completionSep 1999
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
- 35 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
- NCT02273414
- Sponsor's protocol ID
- 543.4
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 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 Repeated Oral Doses (9 Days Dosing) of BIIL 284 BS (Doses: 25 mg, 150 mg, 250 mg as WIF Tablets) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02273414
- Acronym / sponsor ID
- 543.4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1999
- Primary completion
- Sep 1999 (actual)
- First posted
- 24 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 obtain information about the safety and tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary pharmacokinetic data concerning steady state and accumulation factor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIL 284 BS - rising dose | Experimental | Drug: BIIL 284 BS - rising dose |
| 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)
- All participants are healthy males
- Age range from 21 to 50 years
- Broca-Index: within +- 20% of their 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 (15 listed)
- Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- Volunteers with history of orthostatic hypotension, fainting spells or blackouts
- Volunteers with 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 - rising dose | Drug | BIIL 284 BS - rising dose |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant changes in vital signs
Time frame: up to 8 days after last drug administration
Blood pressure, Pulse Rate, Respiratory Rate
Number of subjects with clinically significant changes in 12-lead electrocardiogram
Time frame: up to 8 days after last drug administration
11 secondary outcomes
AUC0-24h (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
Time frame: up to 24 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 80 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 80 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 80 hours after drug administration
MRTtot (Total mean residence time)
Time frame: up to 80 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 80 hours after drug administration
CLtot/F (Total clearance after oral administration)
Time frame: up to 80 hours after drug administration
Ae0-24h (Amount of analyte that is eliminated in urine from 0 to 24 hours)
Time frame: up to 24 hours after drug administration
AUCss (Area under the plasma concentration-time curve at steady state)
Time frame: up to 80 hours after drug administration
Cpre,ss (Predose concentration of the analyte in plasma at steady state)
Time frame: up to 80 hours after drug administration
Changes in Leucotriene B4 (LTB4) induced Mac-1 expression
Time frame: up to 24 hours after last treatment on day 9
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 24 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 - rising dose 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 24 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 adverse events (time frame: up to 8 days after last drug administration). The study lists 4 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 24 Oct 2014.