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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: BI 201335

Study type: Interventional

Funder types: Industry

Identifiers

NCT01580306

2011-005442-35 (EudraCT Number)

1220.58

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

BI 201335 relevant treatment dose (A)

Experimental group

Description:

Capsule for oral administration

Treatment:

Drug: BI 201335

Drug: BI 201335

BI 201335 relevant treatment dose (B)

Experimental group

Description:

Capsule for oral administration

Treatment:

Drug: BI 201335

Drug: BI 201335