A Study of the Effects of GSK189075 on PK Profiles of an... | NCT00504816

Studies
A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers

NCT00504816

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jun 4, 2012Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2

Interventions

GSK189075
Brevicon

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

Start Date

Apr 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jul 13, 2007

First Submission Date that Met QC Criteria

Jul 18, 2007

First Posted Date

Jul 20, 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

May 31, 2012

Last Update Posted Date

Jun 4, 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

Description Module

Brief Summary

The purpose of this research study is to demonstrate a lack of effect of multiple doses of GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the effects of GSK189075 on hormonal levels and on birth control.

Detailed Description

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brevicon	Other	Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.	Drug: GSK189075
GSK189075	Experimental	Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.	Drug: Brevicon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK189075	Drug	Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.	Brevicon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oral contraceptive pill (OC) drug levels		over 24h starting on Day 14
blood hormone levels		on Days 1, 11-14, & 21 of Periods 1 (OC alone) & 3 (OC plus GSK study drug). Period 2 is GSK drug study alone.

Secondary Outcomes

Measure	Description	Time Frame
Adverse events		all visits after study drug
ECGs, Clinical laboratory tests		screening & follow-up
vital signs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy, non-smoking menstruating female age 18 to 45 years old, inclusive.
able to take a specific oral contraceptive & KG2107494.
female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test.
female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner.

Exclusion Criteria:

pregnant or a nursing female.
female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the Follow-up visit.
Have suffered with certain infection within 4 weeks prior to the first dose of study drug

Accepts Healthy Volunteers

Yes

Sex

Female

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		Miramar	Florida	33025	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C020416	norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided