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Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Patients With Hepatic Impairment in Comparison to Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT02265627•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

24 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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)
+7 more criteria

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
+17 more criteria

Key Dates

Start Date

March 1, 2000

Primary Completion Date

September 1, 2000

Last Updated

October 16, 2014

Enrollment

ACTUAL participants

Conditions

Hepatic Insufficiency

Interventions

BIIL 284 BS

DRUG

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

NCT07343037

Hepatic InsufficiencyCirrhosis, Liver

View study

TERMINATEDPHASE1

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

NCT05209295

Hepatic InsufficiencyNeoplasms

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies

A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function

A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants

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Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)