Back to resultsClinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients (DA8159_RI_I)
Primary Purpose
Renal Insufficiency, Kidney Diseases, Urologic Diseases
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Udenafil
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Insufficiency focused on measuring Udenafil, DA-8159, renal impairment, healthy volunteers
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.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Healthy Volunteers
Patients with mild renal impairment
Patients with moderate renal impairment
Patients with severe renal impairment
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics (AUC and Cmax)
Secondary Outcome Measures
Safety
Full Information
NCT ID
NCT01231997
First Posted
November 1, 2010
Last Updated
November 1, 2010
Sponsor
Asan Medical Center
Collaborators
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01231997
Brief Title
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
Acronym
DA8159_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
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Asan Medical Center
Collaborators
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
Udenafil, DA-8159, 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
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Title
Patients with mild renal impairment
Arm Type
Experimental
Arm Title
Patients with moderate renal impairment
Arm Type
Experimental
Arm Title
Patients with severe renal impairment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Udenafil
Intervention Description
100mg Single Oral Dose of
Primary Outcome Measure Information:
Title
Pharmacokinetics (AUC and Cmax)
Time Frame
up to 48 hours
Secondary Outcome Measure Information:
Title
Safety
Time Frame
up to 48 hours
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 ≥ 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.
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 Udenafil Tablet in Renal Impaired Male Patients
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