Clinical Study to Investigate the Safety and Pharmacokine... | NCT01231997

Studies
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

NCT01231997

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Nov 2, 2010Estimated

Enrollment

27Estimated

Phase

Phase 1

Conditions

Renal Insufficiency
Kidney Diseases
Urologic Diseases

Interventions

Udenafil

Countries

South Korea

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

Oct 2010

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

Nov 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Not provided

First Submitted Date

Nov 1, 2010

First Submission Date that Met QC Criteria

Nov 1, 2010

First Posted Date

Nov 2, 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

Nov 1, 2010

Last Update Posted Date

Nov 2, 2010Estimated

Name	Class
Dong-A Pharmaceutical Co., Ltd.	INDUSTRY

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 study is designed to assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.

Detailed Description

Not provided

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

27Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Healthy Volunteers	Experimental	Drug: Udenafil
Patients with mild renal impairment	Experimental	Drug: Udenafil
Patients with moderate renal impairment	Experimental	Drug: Udenafil
Patients with severe renal impairment	Experimental	Drug: Udenafil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Udenafil	Drug	100mg Single Oral Dose of	Healthy Volunteers Patients with mild renal impairment Patients with moderate renal impairment

Measure	Description	Time Frame
Pharmacokinetics (AUC and Cmax)		up to 48 hours

Measure	Description	Time Frame
Safety		up to 48 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult males aged 19 to 64 years at screening.
Subjects with body weight ≥ 55 kg and within ±30% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
Subjects with hypotension or hypertension.
Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyun-Seop Bae, M.D., Ph.D.	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea

Label	URL
Clinical Research Center, Asan Medical Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided