Clinical trial NCT02268149: Study to Evaluate the Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of Prednisone in Healthy Male Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of prednisone


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: AUC (Area under the concentration-time curve of the analyte in plasma)
timeFrame: up to 72 hours post dose
measure: Cmax (Maximum measured concentration of the analyte in plasma)
timeFrame: up to 72 hours post dose
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
timeFrame: up to 72 hours post dose
measure: t½ (Terminal half-life of the analyte in plasma)
timeFrame: up to 72 hours post dose
measure: MRTtot (total Mean residence time)
timeFrame: up to 72 hours post dose
measure: CLtot/F (Total clearance of the analyte in plasma after oral administration)
timeFrame: up to 72 hours post dose
measure: Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
timeFrame: up to 72 hours post dose
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 53 days
measure: Changes in immunomodulatory assessed by T-cell proliferation
timeFrame: predose, 4 hours post dose
measure: Changes in Interleukin-2 (IL-2) levels
timeFrame: predose, 4 hours post dose
measure: Changes in Interferon gamma (IFNy) levels
timeFrame: predose, 4 hours post dose
Other outcomes:
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