Back to resultsClinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients (SK3530_RI_I)
Primary Purpose
Renal Insufficiency, Kidney Diseases, Urologic Diseases
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mirodenafil
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Insufficiency focused on measuring SK-3530, renal impairment, healthy volunteers
Eligibility 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.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Volunteers
Patients with severe renal impairment
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics (AUC and Cmax)
Secondary Outcome Measures
Full Information
NCT ID
NCT01232010
First Posted
November 1, 2010
Last Updated
January 13, 2015
Sponsor
Asan Medical Center
Collaborators
SK Chemicals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01232010
Brief Title
Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients
Acronym
SK3530_RI_I
Official Title
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
SK Chemicals Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Kidney Diseases, Urologic Diseases
Keywords
SK-3530, renal impairment, healthy volunteers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Title
Patients with severe renal impairment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mirodenafil
Intervention Description
50mg Single Oral Dose of
Primary Outcome Measure Information:
Title
Pharmacokinetics (AUC and Cmax)
Time Frame
2days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyun-Seop Bae, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Links:
URL
http://crc.amc.seoul.kr
Description
Clinical Research Center, Asan Medical Center
Learn more about this trial
Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients
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