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

Phase 1

Completed

• Conditions: Renal Insufficiency; Kidney Diseases; Urologic Diseases
• Interventions: Drug: Udenafil

• Registration Number: NCT01231997
• Lead Sponsor: Asan Medical Center

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 available

Study Timeline

• Study Start: 2009-11
• Status Verified: 2010-10
• Primary Completion: 2010-11
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Last Update Submitted: 2010-11-01
• Study First Posted: 2010-11-02
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Udenafil	-
Patients with severe renal impairment	Udenafil	-
Patients with mild renal impairment	Udenafil	-
Patients with moderate renal impairment	Udenafil	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (AUC and Cmax)	up to 48 hours

Secondary Outcome Measures

Name	Time	Method
Safety	up to 48 hours

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of