A Phase 1, Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 30
- Primary Endpoint
- The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403.
Study Overview
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.)
Detailed Description
This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each) as follows:
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •Subject has a BMI >37 kg/m
- •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
Arms & Interventions
Group A
Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment
Intervention: SK-0403 (Drug)
Group B
Subjects with severe renal impairment
Intervention: SK-0403 (Drug)
Group C
Subjects with moderate renal impairment
Intervention: SK-0403 (Drug)
Group D
Subjects with mild renal impairment
Intervention: SK-0403 (Drug)
Group E
Healthy subjects
Intervention: SK-0403 (Drug)
Outcomes
Primary Outcomes
The primary objective is to determine the effect of renal insufficiency on the pharmacokinetics of a single 400 mg dose of SK 0403.
Time Frame: 72 Hours
Secondary Outcomes
- 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)