NCT00956306

Brief Summary

This study is designed to assess the effect of hepatic impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2007

Longer than P75 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, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

4.8 years

First QC Date

August 10, 2009

Last Update Submit

November 22, 2012

Conditions

Hepatic Impairment

Keywords

Udenafil,DA-8159,hepatic impairment,healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (AUC and Cmax), Safety

    up to 72 hours

Study Arms (3)

Child-Pugh A

EXPERIMENTAL
Drug: Udenafil

Child-Pugh B

EXPERIMENTAL
Drug: Udenafil

Healthy Volunteers

EXPERIMENTAL
Drug: Udenafil

Interventions

UdenafilDRUG

100mg Single Oral Dose of Udenafil

Also known as: DA-8159; Zydena
Child-Pugh AChild-Pugh BHealthy Volunteers

Eligibility Criteria

Age20 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males aged 20 to 64 years at screening.
  • Non-smokers
  • In case of hepatic impaired patients
  • In case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients
  • Subjects within ±20% of the ideal body weight
  • 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:

  • History of portosystemic shunt surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

udenafil

Study Officials

  • HYO-SUK LEE, Ph D.

    Seoul National University Hospital

    STUDY CHAIR

  • Young-Suk Lim, Ph D.

    Asan Medical Center, University of Ulsan Colledge of Medicine

    PRINCIPAL INVESTIGATOR

  • Hwi Young Kim, Ph D.

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

  • Sook-Hyang Jeong, Ph D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 11, 2009

Study Start

November 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

KR(1)