Text Size

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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01580306
First received: April 12, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  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 Single Center, Open-label, Parallel-group, Phase 1 Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
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 Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01580306     History of Changes
Other Study ID Numbers: 1220.58, 2011-005442-35
Study First Received: April 12, 2012
Last Updated: April 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on June 18, 2013