A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
A Phase 1, Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
1 other identifier
interventional
30
1 country
2
Brief Summary
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started May 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 10, 2011
February 1, 2011
6 months
May 25, 2010
February 9, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403.
72 Hours
Secondary Outcomes (1)
The secondary objective is to determine the safety and tolerability of a single 400 mg dose of SK 0403 in subjects with renal insufficiency.
72 Hours
Study Arms (5)
Group A
OTHERSubjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment
Group B
OTHERSubjects with severe renal impairment
Group C
OTHERSubjects with moderate renal impairment
Group D
OTHERSubjects with mild renal impairment
Group E
OTHERHealthy subjects
Interventions
Eligibility Criteria
You may qualify if:
- Subject is an adult male or female aged 18 to 79 years, inclusive.
- 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.
You may not qualify if:
- Subject has a BMI \>37 kg/m2.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Minneapolis, Minnesota, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 26, 2010
Study Start
May 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
February 10, 2011
Record last verified: 2011-02