Study to Evaluate the Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of Prednisone in Healthy Male Subjects

NCT ID: NCT02268149

Last Updated: 2014-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIIL 284 BS + Prednisone

BIIL 284 BS 9 days; prednisone 2 single doses

Group Type: EXPERIMENTAL

BIIL 284 BS

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BIIL 284 BS

Intervention Type: DRUG

Prednisone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

543.24

Identifier Type: -

Identifier Source: org_study_id