Single Dose of BI 1744 CL in Patients With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
NCT02171832 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2014-06-24
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
Interventions
- DRUG
-
BI 1744 CL, low dose
- DRUG
-
BI 1744 CL, high dose
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-07-31
- Primary Completion
- 2009-12-31
More Related Trials
-
The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion in Healthy Male Volunteers
NCT02305901 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK
NCT04546789 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems
NCT05661344 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.
NCT02624557 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism and Pharmacokinetics of [14C]-BIBR 953 ZW After Administration of Single Doses of [14C]-BIBR 953 ZW Intravenously or [14C]-BIBR 1048 Oral Solution in Healthy Male Volunteers
NCT02171442 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Pharmacodynamics of BI 1356 in Subjects With Different Degrees of Liver Impairment as Compared to Healthy Subjects
NCT02183376 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How BI 1819479 is Taken up and Processed by the Body
NCT07065617 ·Status: TERMINATED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers
NCT02203487 ·Status: COMPLETED ·Phase: PHASE1
-
To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers
NCT02093819 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers
NCT02161432 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir in Healthy Male Volunteers
NCT02257021 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism and Pharmacokinetics of [14C]-BIBF 1120 in Healthy Male Volunteers
NCT02182154 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL
NCT01587417 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
NCT01187186 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects
NCT02264197 ·Status: COMPLETED ·Phase: PHASE1
-
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
NCT02071121 ·Status: COMPLETED ·Phase: PHASE1
-
Single Rising Peroral Doses of BI 1744 CL in Healthy Volunteers
NCT02171793 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS in Healthy Male Volunteers
NCT02214901 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
NCT03842761 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
NCT04534699 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions
NCT01897597 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906
NCT05296733 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
NCT07165002 ·Status: RECRUITING ·Phase: PHASE1
-
Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers
NCT02223507 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Relative Bioavailability of 11634 Immediate Release Tablet in Healthy Male Volunteers
NCT02214927 ·Status: COMPLETED ·Phase: PHASE1