Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Patients With Hepatic Impairment in Comparison to Healthy Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Hepatic Insufficiency

Treatments

Drug: BIIL 284 BS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02265627

543.26

Details and patient eligibility

About

To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic impairment in comparison to healthy subjects

Enrollment

32 patients

Sex

All

Ages

24 to 70 years old

Volunteers

Accepts Healthy Volunteers

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