HealthyPhase 1NCT02268149
Study to Evaluate the Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of Prednisone in Healthy Male Subjects
A Phase 1 study testing BIIL 284 BS and Prednisone in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of prednisone Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIL 284 BS and Prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent signed and dated prior to participation into the study
- All participants in the study should be healthy males, aged 18-50 years old inclusive
- All participants should be within (+- 20%) of their ideal body weight (Broca-Index)
- Non-smokers (subject who have never smoked) or ex-smoker for at least one year with a smoking history, no greater than five pack-years (1 pack year = 20 cigarettes per day for 1 year)
- Ability to comply with the concomitant therapy restrictions as detailed in Clinical Trial Protocol (CTP)
- Subjects will be off all prescription drugs. O.T.C. drugs must be discontinued for at least two weeks prior to participation in the study. If throughout the study, subjects need any O.T.C. medication, the investigator will call the clinical monitor and this will be reviewed on a case-by-case basis. Restrictions for different medications are described in CTP
- Subjects will have no evidence of clinically relevant concomitant disease based upon complete medical history, full physical examination, chest-x-ray (if not done in previous 6 months), ECG and clinical laboratory tests
Who cannot join
- Viral respiratory tract infection or a respiratory tract infection within the six weeks preceding dosing with study medication
- Small or difficult to locate arm or hand veins that would impair the clinicians ability to draw blood samples or to place a venous catheter
- Subjects with a known drug or alcohol dependence (absence of dependency for 10 years) or who drink more than 60 g of alcohol per day, history of significant allergic reactions to drugs or sensitivity to aspirin or positive drug screen
- Use of investigational new drug in the preceding month or six half-lives (whichever is greater) prior to the first screen at Visit 1
- Donation of blood during the month preceding Visit 1
- Subjects receiving hyposensitization therapy who are not on a stable dose for the last three months before Visit 1
Show all 14Show fewer
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- Subjects with known history of orthostatic hypotension, fainting spells or blackouts
- Subjects with chronic or relevant acute infections
- Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Subjects with eosinophilia > 7 %
- Subjects who received any other drugs, which might influence the results of the trial during the weeks prior to dosing with study medication
- Subjects who participated in excessive physical activities (e.g. competitive sports) within the last week before dosing with study medication
About this study
Official title: The Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Male Subjects (A Randomized, Double-blind, Placebo-controlled, Two Period, Two-way Cross-over Study)
Study to evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of prednisone
- Conditions
- Healthy
- Being tested
- BIIL 284 BS, Prednisone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIL 284 BSDrug
PrednisoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIL 284 BS + Prednisone | Experimental | BIIL 284 BS 9 days; prednisone 2 single doses Receives: Drug: BIIL 284 BS; Drug: Prednisone |
| 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.
AUC (Area under the concentration-time curve of the analyte in plasma)
Measured: up to 72 hours post dose
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours post dose
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 72 hours post dose
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 72 hours post dose
MRTtot (total Mean residence time)
Measured: up to 72 hours post dose
CLtot/F (Total clearance of the analyte in plasma after oral administration)
Measured: up to 72 hours post dose
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Measured: up to 72 hours post dose
Secondary outcomes (4)
Number of subjects with adverse events
Measured: up to 53 days
Changes in immunomodulatory assessed by T-cell proliferation
Measured: predose, 4 hours post dose
Changes in Interleukin-2 (IL-2) levels
Measured: predose, 4 hours post dose
Changes in Interferon gamma (IFNy) levels
Measured: predose, 4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startApr 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
- Crossover
- Masking
- Double blind
- Enrolment
- 20 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
- NCT02268149
- Sponsor's protocol ID
- 543.24
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Male Subjects (A Randomized, Double-blind, Placebo-controlled, Two Period, Two-way Cross-over Study)
- ClinicalTrials.gov ID
- NCT02268149
- Acronym / sponsor ID
- 543.24
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Primary completion
- Jul 2000 (actual)
- First posted
- 20 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 evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of prednisone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIL 284 BS + Prednisone | Experimental | Drug: BIIL 284 BS, Drug: PrednisoneBIIL 284 BS 9 days; prednisone 2 single doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent signed and dated prior to participation into the study
- All participants in the study should be healthy males, aged 18-50 years old inclusive
- All participants should be within (+- 20%) of their ideal body weight (Broca-Index)
- Non-smokers (subject who have never smoked) or ex-smoker for at least one year with a smoking history, no greater than five pack-years (1 pack year = 20 cigarettes per day for 1 year)
- Ability to comply with the concomitant therapy restrictions as detailed in Clinical Trial Protocol (CTP)
Key exclusion criteria (14 listed)
- Viral respiratory tract infection or a respiratory tract infection within the six weeks preceding dosing with study medication
- Small or difficult to locate arm or hand veins that would impair the clinicians ability to draw blood samples or to place a venous catheter
- Subjects with a known drug or alcohol dependence (absence of dependency for 10 years) or who drink more than 60 g of alcohol per day, history of significant allergic reactions to drugs or sensitivity to aspirin or positive drug screen
- Use of investigational new drug in the preceding month or six half-lives (whichever is greater) prior to the first screen at Visit 1
- Donation of blood during the month preceding Visit 1
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 | Drug | BIIL 284 BS + Prednisone |
| Prednisone | Drug | BIIL 284 BS + Prednisone |
| Placebo | Drug | Placebo |
Primary outcome
AUC (Area under the concentration-time curve of the analyte in plasma)
Time frame: up to 72 hours post dose
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours post dose
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 72 hours post dose
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 72 hours post dose
MRTtot (total Mean residence time)
Time frame: up to 72 hours post dose
CLtot/F (Total clearance of the analyte in plasma after oral administration)
Time frame: up to 72 hours post dose
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 72 hours post dose
4 secondary outcomes
Number of subjects with adverse events
Time frame: up to 53 days
Changes in immunomodulatory assessed by T-cell proliferation
Time frame: predose, 4 hours post dose
Changes in Interleukin-2 (IL-2) levels
Time frame: predose, 4 hours post dose
Changes in Interferon gamma (IFNy) levels
Time frame: predose, 4 hours post dose
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 20 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 and Prednisone 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 7 inclusion and 14 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 20 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?
AUC (Area under the concentration-time curve of the analyte in plasma) (time frame: up to 72 hours post dose). The study lists 7 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 20 Oct 2014.