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

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: BI 201335

• Registration Number: NCT01580306
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-07
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-03
• Last Update Submitted: 2015-07-03
• Results First Posted: 2015-07-31
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 201335 relevant treatment dose (A)	BI 201335	Capsule for oral administration
BI 201335 relevant treatment dose (B)	BI 201335	Capsule for oral administration

Primary Outcome Measures

Name	Time	Method
AUC0-∞	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	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	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	maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.

Secondary Outcome Measures

Name	Time	Method
Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG	from drug administration up to 2 weeks	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	drug administration until end-of-study examination (7 to 14 days after drug administration)	number of participants with investigator-defined drug related adverse events.

Trial Locations

Locations (1)

1220.58.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Kiel, Germany