A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
NCT ID: NCT01131091
Last Updated: 2011-02-10
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
30 participants
INTERVENTIONAL
2010-05-31
2010-11-30
Brief Summary
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Detailed Description
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Group A: Subjects with ESRD who are receiving hemodialysis treatment
Group B: Subjects with severe renal impairment
Group C: Subjects with moderate renal impairment
Group D: Subjects with mild renal impairment
Group E: Healthy subjects
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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Group A
Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment
SK-0403
SK-0403 400 mg
Group B
Subjects with severe renal impairment
SK-0403
SK-0403 400 mg
Group C
Subjects with moderate renal impairment
SK-0403
SK-0403 400 mg
Group D
Subjects with mild renal impairment
SK-0403
SK-0403 400 mg
Group E
Healthy subjects
SK-0403
SK-0403 400 mg
Interventions
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SK-0403
SK-0403 400 mg
Eligibility Criteria
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Inclusion Criteria
* All female subjects (that are not 2 years postmenopausal with a documented serum follicle stimulating hormone level \>35 mIU/mL) must have a negative serum pregnancy test at Screening and upon Check in to the study clinic.
* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is able and willing to comply with the protocol and study procedures.
Exclusion Criteria
* Subject has taken any prescribed systemic or topical medication
* Subject has donated more than 450 mL of blood within 30 days before the start of dosing.
* Subject has received an investigational drug within 30 days before dosing.
* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption.
* Subject has had a clinically significant illness
18 Years
79 Years
ALL
Yes
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Kowa Research Institute, Inc.
Locations
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Orlando, Florida, United States
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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SK-0403-1.02US
Identifier Type: -
Identifier Source: org_study_id
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