NCT01231997

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
Last Updated

November 2, 2010

Status Verified

October 1, 2010

Enrollment Period

1 year

First QC Date

November 1, 2010

Last Update Submit

November 1, 2010

Conditions

Renal InsufficiencyKidney DiseasesUrologic Diseases

Keywords

UdenafilDA-8159renal impairmenthealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (AUC and Cmax)

    up to 48 hours

Secondary Outcomes (1)

  • Safety

    up to 48 hours

Study Arms (4)

Healthy Volunteers

EXPERIMENTAL
Drug: Udenafil

Patients with mild renal impairment

EXPERIMENTAL
Drug: Udenafil

Patients with moderate renal impairment

EXPERIMENTAL
Drug: Udenafil

Patients with severe renal impairment

EXPERIMENTAL
Drug: Udenafil

Interventions

UdenafilDRUG

100mg Single Oral Dose of

Healthy VolunteersPatients with mild renal impairmentPatients with moderate renal impairmentPatients with severe renal impairment

Eligibility Criteria

Age19 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

Renal InsufficiencyKidney DiseasesUrologic Diseases

Interventions

udenafil

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Kyun-Seop Bae, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Last Updated

November 2, 2010

Record last verified: 2010-10

Locations

KR(1)