A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403

Kowa Research Institute, Inc.30 enrolled

Overview

This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are planned (5 groups of 6 subjects each.)

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 Group E: Healthy subjects

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

SK-0403DRUG

SK-0403 400 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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/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

Locations (2)

Unnamed facility

Orlando, Florida, United States

Unnamed facility

Minneapolis, Minnesota, United States

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.

Time frame: 72 Hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.