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: July 3, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: BI 201335
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUC0-∞ [ Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration ] [ Designated as safety issue: No ]

    area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.

    In this endpoint, the data of AUC0-∞ show inter-individual variabilities.


  • Cmax [ Time Frame: 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration ] [ Designated as safety issue: No ]
    maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.


Secondary Outcome Measures:
  • Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG [ Time Frame: from drug administration up to 2 weeks ] [ Designated as safety issue: No ]
    Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

  • Number of Participants With Drug Related Adverse Events [ Time Frame: drug administration until end-of-study examination (7 to 14 days after drug administration) ] [ Designated as safety issue: No ]
    number of participants with investigator-defined drug related adverse events.


Enrollment: 32
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 201335 relevant treatment dose (A)
Capsule for oral administration
Drug: BI 201335
Relevant treatment dose capsule (A) for oral administration
Experimental: BI 201335 relevant treatment dose (B)
Capsule for oral administration
Drug: BI 201335
Relevant treatment dose capsule (B) for oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580306

Locations
Germany
1220.58.1 Boehringer Ingelheim Investigational Site
Kiel, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01580306     History of Changes
Other Study ID Numbers: 1220.58, 2011-005442-35
Study First Received: April 12, 2012
Results First Received: July 3, 2015
Last Updated: July 3, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 02, 2015