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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Prednisone

Drug: BIIL 284 BS

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02268149

543.24

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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