A Multicenter, Open Label, Single Dose Study to Evaluate... | NCT01131091

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

NCT01131091

Sponsor

Kowa Research Institute, Inc.

Status

Completed

Last Update Posted

Feb 10, 2011Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

SK-0403

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

May 25, 2010

First Submission Date that Met QC Criteria

May 25, 2010

First Posted Date

May 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2011

Last Update Posted Date

Feb 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Group E: Healthy subjects

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Other	Subjects with end stage renal disease (ESRD) who are receiving hemodialysis treatment	Drug: SK-0403
Group B	Other	Subjects with severe renal impairment	Drug: SK-0403
Group C	Other	Subjects with moderate renal impairment	Drug: SK-0403
Group D	Other	Subjects with mild renal impairment	Drug: SK-0403
Group E	Other	Healthy subjects	Drug: SK-0403

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SK-0403	Drug	SK-0403 400 mg	Group A Group B Group C Group D Group E

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Orlando	Florida		United States