Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease
NCT ID: NCT01886599
Last Updated: 2013-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2012-11-30
2013-02-28
Brief Summary
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Detailed Description
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Other: The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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Arm A: Subjects with normal renal function
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Asunaprevir
Arm B: Subjects with end stage renal disease
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Asunaprevir
Arm C: Subjects with mild renal impairment
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Asunaprevir
Arm D: Subjects with moderate renal impairment
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Asunaprevir
Arm E: Subjects with severe renal impairment
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
Asunaprevir
Interventions
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Asunaprevir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Group B: Patients with end stage renal disease
* Group C: Patients with mild renal impairment
* Group D: Patients with moderate renal impairment
* Group E: Patients with severe renal impairment
Exclusion Criteria
* Hepatitis B or C
* Human Immunodeficiency Virus (HIV)
* Recent gastrointestinal disease
18 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Orlando Clinical Research Center
Orlando, Florida, United States
Davita Clinical Research
Minneapolis, Minnesota, United States
New Orleans Center For Clinical Research
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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AI447-033
Identifier Type: -
Identifier Source: org_study_id