- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02265627
Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Patients With Hepatic Impairment in Comparison to Healthy Volunteers
October 15, 2014 updated by: Boehringer Ingelheim
Pharmacokinetics, Safety and Tolerability of Single Dose BIIL 284 BS in Patients With Hepatic Impairment in Comparison to Healthy Subjects (An Open Label, Matched Pair, Two Center Study)
To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic impairment in comparison to healthy subjects
Study Overview
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
24 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Healthy Subjects
- Written informed consent signed and dated prior to participation into the study (including medication washout)
- Male of female 24-70 years of age
- All subjects should be within (+- 20 %) of their ideal body weight (Broca-Index)
- Healthy subjects must be able to be comparably matched to a hepatic impaired patient according to age (+- 5 years), weight (+- 30 lbs), gender, and smoking status
- Volunteers will have no evidence of clinically relevant concomitant disease based upon the following: a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, complete blood count (CBC) with differential and platelets, prothrombin time (PT), blood chemistry, hematology and urinalysis
- Female subjects need to be of non-childbearing potential (post-menopausal), tubal ligation or total hysterectomy) and had to provide a negative pregnancy test at the screening visit or subjects is a male
- Tested negative at the screening visit for the following drug screen panel (barbiturates, benzodiazepines, amphetamines, opiates, cocaine, cannabinoids)
Patients with hepatic impairment
- Written informed consent signed and dated prior to participation into the study (including medication washout)
- Male of female 24-70 years of age
- All subjects should be within (+- 20 %) of their ideal body weight (Broca-Index)
- Proven history of cirrhosis confirmed by liver/spleen scan or biopsy (within one year)
- Hepatic impairment: A Child-Pugh classification of Class A, or B
- Volunteers will have no evidence of clinically relevant concomitant disease (other than hepatic impairment) based upon the following: a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, CBC with differential and platelets, prothrombin time (PT), blood chemistry, hematology and urinalysis
- Tested negative at the screening visit for the following drug screen panel (barbiturates, benzodiazepines, amphetamines, opiates, cocaine, cannabinoids). Unless known drugs were being used for medicinal reasons. For this reason the sponsor and investigator were notified
- Female patients were of non-childbearing potential (post-menopausal), tubal ligation or total hysterectomy) and had to provide a negative pregnancy test at the screening visit
Exclusion Criteria:
Healthy subjects
- Tested positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody
- Have a significant acute or chronic disease, which could have interfered with the objectives of the study
- Small or difficult to locate arm or hand veins that would impair the clinician's ability to draw multiple blood samples or to place a venous catheter
- Likely to need concomitant medication during the study period, which could interfere with the objectives of the study
- Had given a blood donation during the month preceding the study drug administration
- Alcohol consumption > 2 drinks daily (one drink defined as: 12 ounces of beer, 4 ounces of wine or 1.5 ounces of spirits)
- Coffee or tea consumption > 3 cups per day or xanthine containing drinks > 0.5 liter/day
- History of any clinically significant hematological, respiratory, cardiovascular, renal or central nervous system (CNS) disease or other medical condition that is capable of altering the metabolism or elimination of drugs, or of constituting a risk factor when taking the study drug
- History of drug addiction or alcoholism
- Any medical or psychological condition which could relapse during or immediately after the study
- Use of any drug or nutrient which could induce or inhibit hepatic microsomal enzymes within one month of the start of the study or longer based on the elimination half-life of the drug
- Use of experimental new drug one month prior to study drug administration
- Consumed any medicine whatsoever (including over the counter (OTC) drugs) within two weeks of the scheduled administration of the study drug
Patients with Hepatic Impairment
- Positive serology for HIV
- Have a significant acute or chronic disease (except hepatic disease), which is unstable or could interfere with the objectives of the study
- Small or difficult to locate arm or hand veins that would impair the clinician's ability to draw multiple blood samples or to place a venous catheter
- Have hepatocellular carcinoma, extrahepatic biliary obstruction, surgical portal-systemic shunting, acute hepatitis of any origin
- Digestive bleeding within one month of inclusion
- Likely to need concomitant medication during the study period, which could interfere with the objectives of the study
- Had given a blood donation during the month preceding study entry
- Coffee or tea consumption > 3 cups per day or xanthine containing drinks > 0.5 liter/day
- History of any clinically significant hematological, respiratory, cardiovascular, renal or CNS disease or other medical condition (except hepatic impairment) that is capable of altering the metabolism or elimination of drugs, or of constituting a risk factor when taking the study drug
- Any medical or psychological condition which could relapse during or immediately after the study
- Use of any drug or nutrient which could induce or inhibit hepatic microsomal enzymes within one month of the start of the study or longer based on the elimination half-life of the drug
- Use of experimental new drug within the previous month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BIIL 284 BS, normal hepatic function
|
|
Experimental: BIIL 284 BS, mild hepatic impairment
|
|
Experimental: BIIL 284 BS, moderate hepatic impairment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentration-time profiles of the analytes at different time points
Time Frame: Up to 84 hours after drug administration
|
Up to 84 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum measured concentration of BIIL 315 ZW in plasma (Cmax)
Time Frame: Up to 84 hours after drug administration
|
Up to 84 hours after drug administration
|
|
Time from dosing to the maximum concentration of BIIL 315 ZW in plasma (tmax)
Time Frame: Up to 84 hours after drug administration
|
Up to 84 hours after drug administration
|
|
Area under the concentration-time curve of BIIL 315 ZW in plasma at different time points (AUC)
Time Frame: Up to 84 hours after drug administration
|
Up to 84 hours after drug administration
|
|
Terminal half-life of BIIL 315 ZW in plasma (t1/2)
Time Frame: Up to 84 hours after drug administration
|
Up to 84 hours after drug administration
|
|
Total mean residence time of BIIL 315 ZW in the body (MRTtot)
Time Frame: Up to 84 hours after drug administration
|
Up to 84 hours after drug administration
|
|
Total apparent clearance of BIIL 315 ZW in plasma after oral administration (CLtot/F)
Time Frame: Up to 84 hours after drug administration
|
Up to 84 hours after drug administration
|
|
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time Frame: Up to 84 hours after drug administration
|
Up to 84 hours after drug administration
|
|
Number of patients with clinically relevant findings in vital signs
Time Frame: Up to 4 days after drug administration
|
blood pressure, pulse rate
|
Up to 4 days after drug administration
|
Changes from baseline in spirometry
Time Frame: Pre-dose and 1 hour after drug administration
|
Pre-dose and 1 hour after drug administration
|
|
Number of patients with clinically relevant findings in laboratory tests
Time Frame: Up to 4 days after drug administration
|
Up to 4 days after drug administration
|
|
Number of patients with clinically relevant findings in 12-lead ECG
Time Frame: Up to 4 days after drug administration
|
Up to 4 days after drug administration
|
|
Changes from baseline in physical examination
Time Frame: Pre-dose and 4 days after drug administration
|
Pre-dose and 4 days after drug administration
|
|
Number of patients with adverse events
Time Frame: Up to 11 days after drug administration
|
Up to 11 days after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2000
Primary Completion (Actual)
September 1, 2000
Study Registration Dates
First Submitted
October 15, 2014
First Submitted That Met QC Criteria
October 15, 2014
First Posted (Estimate)
October 16, 2014
Study Record Updates
Last Update Posted (Estimate)
October 16, 2014
Last Update Submitted That Met QC Criteria
October 15, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 543.26
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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