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

This study has been completed.
Sponsor:
Collaborator:
SK Chemicals Co.,Ltd.
Information provided by (Responsible Party):
Kyun-Seop Bae, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01232010
First received: November 1, 2010
Last updated: January 13, 2015
Last verified: January 2015
  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 ]

Enrollment: 12
Study Start Date: November 2009
Primary Completion Date: December 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
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:
No publications provided

Responsible Party: Kyun-Seop Bae, Principal Investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01232010     History of Changes
Other Study ID Numbers: 2007-0445
Study First Received: November 1, 2010
Last Updated: January 13, 2015
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
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on September 02, 2015