Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients - Full Text View

Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients (SK3530_RI_I)

This study is currently recruiting participants.

Verified October 2010 by Asan Medical Center

First Received on November 1, 2010. No Changes Posted

Sponsor:	Asan Medical Center
Collaborator:	SK Chemicals Co.,Ltd.
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT01232010

Purpose

This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.

Condition	Intervention	Phase
Renal Insufficiency Kidney Diseases Urologic Diseases	Drug: Mirodenafil	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Pharmacokinetics (AUC and Cmax) [ Time Frame: 2days ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	November 2009
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Healthy Volunteers	Drug: Mirodenafil 50mg Single Oral Dose of
Experimental: Patients with severe renal impairment	Drug: Mirodenafil 50mg Single Oral Dose of

Eligibility

Ages Eligible for Study:	19 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adult males aged 19 to 64 years at screening.
Subjects with body weight ≥ 50 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 deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232010

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of
Contact: Kyun-Seop Bae, M.D., Ph.D. 02-3010-4622 ext No
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D.

Sponsors and Collaborators

Asan Medical Center

SK Chemicals Co.,Ltd.

Investigators

Principal Investigator:

Kyun-Seop Bae, M.D., Ph.D.

Asan Medical Center

More Information

Additional Information:

Clinical Research Center, Asan Medical Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical Research Team, SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT01232010 History of Changes
Other Study ID Numbers:	2007-0445
Study First Received:	November 1, 2010
Last Updated:	November 1, 2010
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:

SK-3530
renal impairment
healthy volunteers

Additional relevant MeSH terms:

Kidney Diseases
Urologic Diseases
Renal Insufficiency
Mirodenafil
Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012