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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 201335 relevant treatment dose (A)

Capsule for oral administration

Group Type EXPERIMENTAL

BI 201335

Intervention Type DRUG

Relevant treatment dose capsule (A) for oral administration

BI 201335 relevant treatment dose (B)

Capsule for oral administration

Group Type EXPERIMENTAL

BI 201335

Intervention Type DRUG

Relevant treatment dose capsule (B) for oral administration

Interventions

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BI 201335

Relevant treatment dose capsule (A) for oral administration

Intervention Type DRUG

BI 201335

Relevant treatment dose capsule (B) for oral administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes