Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01580306
First received: April 12, 2012
Last updated: October 31, 2013
Last verified: October 2013

April 12, 2012
October 31, 2013
April 2012
June 2012   (final data collection date for primary outcome measure)
  • AUC0-infinity (area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity) [ Time Frame: Up to 6 days ] [ Designated as safety issue: No ]
  • Cmax (maximum concentration of the analyte in plasma) [ Time Frame: Up to 6 days ] [ Designated as safety issue: No ]
  • AUC0-infinity (area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity) [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01580306 on ClinicalTrials.gov Archive Site
  • Changes from baseline in vital signs [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in electrocardiogram (ECG) results [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline laboratory measurements [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant findings in physical examination [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
Pharmacokinetics, Safety and Tolerability of BI 201335 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase I Trial

The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
  • Drug: BI 201335
    Relevant treatment dose capsule (A) for oral administration
  • Drug: BI 201335
    Relevant treatment dose capsule (B) for oral administration
  • Experimental: BI 201335 relevant treatment dose (A)
    Capsule for oral administration
    Intervention: Drug: BI 201335
  • Experimental: BI 201335 relevant treatment dose (B)
    Capsule for oral administration
    Intervention: Drug: BI 201335
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

Male and female healthy subjects with normal renal function and subjects with impaired renal function in relatively good health

Exclusion criteria:

Any relevant deviation from healthy conditions for healthy volunteers or significant diseases other than renal impairment for the renal impaired subjects

Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01580306
1220.58, 2011-005442-35
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP