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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BIIL 284 BS, normal hepatic function
Drug: BIIL 284 BS
Experimental: BIIL 284 BS, mild hepatic impairment
Drug: BIIL 284 BS
Experimental: BIIL 284 BS, moderate hepatic impairment
Drug: BIIL 284 BS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2000

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2000

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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