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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Prednisone; Drug: BIIL 284 BS

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BIIL 284 BS + Prednisone; BIIL 284 BS 9 days; prednisone 2 single doses	Drug: Prednisone; Drug: BIIL 284 BS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC (Area under the concentration-time curve of the analyte in plasma)	up to 72 hours post dose
Cmax (Maximum measured concentration of the analyte in plasma)	up to 72 hours post dose
tmax (Time from dosing to the maximum concentration of the analyte in plasma)	up to 72 hours post dose
t½ (Terminal half-life of the analyte in plasma)	up to 72 hours post dose
MRTtot (total Mean residence time)	up to 72 hours post dose
CLtot/F (Total clearance of the analyte in plasma after oral administration)	up to 72 hours post dose
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)	up to 72 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	up to 53 days
Changes in immunomodulatory assessed by T-cell proliferation	predose, 4 hours post dose
Changes in Interleukin-2 (IL-2) levels	predose, 4 hours post dose
Changes in Interferon gamma (IFNy) levels	predose, 4 hours post dose

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (Actual): July 1, 2000

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Estimate): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 16, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: 543.24