Hepatic InsufficiencyPhase 1NCT02265627

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

A Phase 1 study testing BIIL 284 BS in people with Hepatic Insufficiency, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 24 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Insufficiency
What is being tested?: BIIL 284 BS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: No sites listed yet
Study dates: Mar 2000to Sep 2000
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

About this study

Official title: 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

Conditions: Hepatic Insufficiency
Being tested: BIIL 284 BS
Medical subject headings: Hepatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIIL 284 BSDrug

Study groups in NCT02265627
Study group	Role	What they receive
BIIL 284 BS, normal hepatic function	Experimental	Not described Receives: Drug: BIIL 284 BS
BIIL 284 BS, mild hepatic impairment	Experimental	Not described Receives: Drug: BIIL 284 BS
BIIL 284 BS, moderate hepatic impairment	Experimental	Not described Receives: Drug: BIIL 284 BS

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma concentration-time profiles of the analytes at different time points
Measured: Up to 84 hours after drug administration

Secondary outcomes (13)

Maximum measured concentration of BIIL 315 ZW in plasma (Cmax)
Measured: Up to 84 hours after drug administration
Time from dosing to the maximum concentration of BIIL 315 ZW in plasma (tmax)
Measured: Up to 84 hours after drug administration
Area under the concentration-time curve of BIIL 315 ZW in plasma at different time points (AUC)
Measured: Up to 84 hours after drug administration
Terminal half-life of BIIL 315 ZW in plasma (t1/2)
Measured: Up to 84 hours after drug administration
Total mean residence time of BIIL 315 ZW in the body (MRTtot)
Measured: Up to 84 hours after drug administration
Total apparent clearance of BIIL 315 ZW in plasma after oral administration (CLtot/F)
Measured: Up to 84 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Measured: Up to 84 hours after drug administration
Number of patients with clinically relevant findings in vital signs
blood pressure, pulse rate
Measured: Up to 4 days after drug administration
Changes from baseline in spirometry
Measured: Pre-dose and 1 hour after drug administration
Number of patients with clinically relevant findings in laboratory tests
Measured: Up to 4 days after drug administration
Number of patients with clinically relevant findings in 12-lead ECG
Measured: Up to 4 days after drug administration
Changes from baseline in physical examination
Measured: Pre-dose and 4 days after drug administration
Number of patients with adverse events
Measured: Up to 11 days after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2000Sep 2000

First posted16 Oct 2014 (estimated)
Study startMar 2000
Primary completionSep 2000

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02265627
Sponsor's protocol ID: 543.26
Status last verified: Oct 2014
First submitted: 15 Oct 2014
Last updated: 16 Oct 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hepatic Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02265627
Acronym / sponsor ID: 543.26
Conditions: Hepatic Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2000
Primary completion: Sep 2000 (actual)
First posted: 16 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 24 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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

Key exclusion criteria (27 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BIIL 284 BS	Drug	BIIL 284 BS, mild hepatic impairment, BIIL 284 BS, moderate hepatic impairment, BIIL 284 BS, normal hepatic function

Primary outcome

Plasma concentration-time profiles of the analytes at different time points
Time frame: Up to 84 hours after drug administration

13 secondary outcomes

Maximum measured concentration of BIIL 315 ZW in plasma (Cmax)
Time frame: 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
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
Terminal half-life of BIIL 315 ZW in plasma (t1/2)
Time frame: 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
Total apparent clearance of BIIL 315 ZW in plasma after oral administration (CLtot/F)
Time frame: 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
Number of patients with clinically relevant findings in vital signs
Time frame: Up to 4 days after drug administration
Changes from baseline in spirometry
Time frame: 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
Number of patients with clinically relevant findings in 12-lead ECG
Time frame: Up to 4 days after drug administration
Changes from baseline in physical examination
Time frame: Pre-dose and 4 days after drug administration
Number of patients with adverse events
Time frame: Up to 11 days after drug administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.

Related trials for Hepatic Insufficiency

Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIIL 284 BS in people with Hepatic Insufficiency, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma concentration-time profiles of the analytes at different time points (time frame: Up to 84 hours after drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02265627.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.