Single Dose of BI 1744 CL in Patients With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

NCT02171832 | Completed Phase 1

• 1 other identifier: 1222.20
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this study was to investigate the influence of mild and moderate liver impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744 CL in comparison to a control group with normal hepatic function after single orally inhaled administration of BI 1744 CL with the Respimat® Inhaler.

Conditions

Healthy; Liver Diseases

Outcome Measures

Primary Outcomes (2)

• AUC0-∞,norm (dose-normalized area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration

• Cmax,norm (dose-normalized maximum concentration of the analyte in plasma)

  before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration

Secondary Outcomes (21)

• AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration

• Cmax (maximum concentration of the analyte in plasma)

  before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration

• AUC0-tz(,norm) ((dose-normalized ) area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration

• %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)

  before and 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, and 72:00 hours following drug administration

Study Arms (3)

Mildly liver impaired patients

EXPERIMENTAL

Drug: BI 1744 CL, low dose

Moderately liver impaired patients

EXPERIMENTAL

Drug: BI 1744 CL, low dose

Healthy volunteers

EXPERIMENTAL

Drug: BI 1744 CL, high dose

Interventions

BI 1744 CL, low dose DRUG

Mildly liver impaired patients; Moderately liver impaired patients

BI 1744 CL, high dose DRUG

Healthy volunteers

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects:
• Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests. The healthy subjects must meet the matching criteria based on the matching approach
• Age \>21 and \<75 years
• Body Mass Index (BMI) \>18.5 and \<32 kg/m2
• Creatinine clearance \>70 mL/min according to Cockcroft \& Gault
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
• Hepatically impaired subjects:
• Hepatically male and female impaired subjects determined by results of screening classified as
• Group 1 (Child-Pugh A; Child-Pugh score of 5-6 points) and as
• Group 2 (Child-Pugh B; Child-Pugh score of 7-9 points)
• Age \>21 and \<75 years
• BMI \>18.5 and \<34 kg/m2
• Creatinine clearance \>40 mL/min according to Cockcroft \& Gault (for hepatically impaired patients)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

You may not qualify if:

• Healthy subjects who meet any of the following criteria will not be entered into this trial:
• Any finding of the medical examination (including BP \[\>140 mmHg systolic and or \>95 mmHg diastolic\], PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Relevant gastrointestinal tract surgery (except appendectomy, herniotomy)
• Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections (e.g. including Hepatitis B and C and HIV)
• History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
• History or presence of allergy against iodine and/or contrast agent, latent or manifest hyperthyrosis or allergic diathesis to indocyanine green
• Intake of drugs that are contraindicated in connection with the indocyanine green test
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Participation in another trial with an investigational drug within one month after previous single dose administration or two months after previous multiple dose administration prior to administration or during the trial
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking when confined to the study site on trial days

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

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: June 20, 2014
• First Posted: June 24, 2014
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: June 24, 2014

Record last verified: 2014-06