A First Time in Human Study in Healthy Male Volunteers fo... | NCT00549211

Studies
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.

NCT00549211

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Mar 19, 2012Estimated

Enrollment

42Estimated

Phase

Phase 1

Conditions

Obstetric Labour, Premature
Premature Ejaculation

Interventions

GSK557296

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 23, 2007

First Submission Date that Met QC Criteria

Oct 23, 2007

First Posted Date

Oct 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2012

Last Update Posted Date

Mar 19, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Name	Type	Description	Arm Group Labels	Other Names
GSK557296	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs		24 Hours

Secondary Outcomes

Measure	Description	Time Frame
Blood tests to study how long the drug stays in your blood		24 Hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males who are 18 to 45 years of age
Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician
Non-smokers

Exclusion Criteria:

Alcohol consumption averaging more than 7 drinks per week
Positive for Hepatitis C antibody, Hepatitis B antigen or HIV
Any use of prescription drugs or non prescription drugs

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Evansville	Indiana	47714	United States

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D061686	Premature Ejaculation

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided