NCT00443625

Brief Summary

This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_1

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

December 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

February 22, 2007

Last Update Submit

April 16, 2013

Conditions

Erectile Dysfunction

Keywords

SK3530Food effectPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • PK parameters - AUC, Cmax, Tmax

Secondary Outcomes (1)

  • PK parameters-t1/2

Interventions

SK3530DRUG

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ages 19 to 50
  • body weight of (IBM) ± 20%

You may not qualify if:

  • cardiovascular disease
  • color-blindness or weakness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo(3,2-d)pyrimidin-4-one dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • In-Jin Jang, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2007

First Posted

March 6, 2007

Study Start

December 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

April 18, 2013

Record last verified: 2013-04