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

NCT02265627 | Completed Phase 1

• 1 other identifier: 543.26
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (1)

• Plasma concentration-time profiles of the analytes at different time points

  Up to 84 hours after drug administration

Secondary Outcomes (13)

• Maximum measured concentration of BIIL 315 ZW in plasma (Cmax)

  Up to 84 hours after drug administration

• Time from dosing to the maximum concentration of BIIL 315 ZW in plasma (tmax)

  Up to 84 hours after drug administration

• Area under the concentration-time curve of BIIL 315 ZW in plasma at different time points (AUC)

  Up to 84 hours after drug administration

• Terminal half-life of BIIL 315 ZW in plasma (t1/2)

  Up to 84 hours after drug administration

• Total mean residence time of BIIL 315 ZW in the body (MRTtot)

  Up to 84 hours after drug administration

Study Arms (3)

BIIL 284 BS, normal hepatic function

EXPERIMENTAL

Drug: BIIL 284 BS

BIIL 284 BS, mild hepatic impairment

EXPERIMENTAL

Drug: BIIL 284 BS

BIIL 284 BS, moderate hepatic impairment

EXPERIMENTAL

Drug: BIIL 284 BS

Interventions

BIIL 284 BS DRUG

BIIL 284 BS, mild hepatic impairment; BIIL 284 BS, moderate hepatic impairment; BIIL 284 BS, normal hepatic function

Eligibility Criteria

• Age: 24 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

amelubant

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 16, 2014
• Study Start: March 1, 2000
• Primary Completion: September 1, 2000
• Last Updated: October 16, 2014

Record last verified: 2014-10