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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580306
• Other study ID #: 1220.58
• Secondary ID: 2011-005442-35
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2012
• Last updated: July 3, 2015
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Renal Insufficiency

Intervention

Drug:
• BI 201335
Relevant treatment dose capsule (A) for oral administration
• BI 201335
Relevant treatment dose capsule (B) for oral administration

Locations

Country	Name	City	State
Germany	1220.58.1 Boehringer Ingelheim Investigational Site	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-8	area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.; In this endpoint, the data of AUC0-8 show inter-individual variabilities.	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	No
Primary	Cmax	maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.	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	No
Secondary	Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG	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.	from drug administration up to 2 weeks	No
Secondary	Number of Participants With Drug Related Adverse Events	number of participants with investigator-defined drug related adverse events.	drug administration until end-of-study examination (7 to 14 days after drug administration)	No

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