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

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Kidney Diseases; Renal Insufficiency; Urologic Diseases

Treatments: Drug: Mirodenafil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01232010

2007-0445

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Healthy Volunteers

Experimental group

Treatment:

Drug: Mirodenafil

Patients with severe renal impairment

Experimental group

Treatment:

Drug: Mirodenafil