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

Tracking Information

First Received Date ^ICMJE

July 13, 2007

Last Updated Date

October 9, 2008

Start Date ^ICMJE

April 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00504816 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ECGs, Clinical laboratory tests [ Time Frame: screening & follow-up ]
vital signs [ Time Frame: screening;Day 13, Period 1 & 3; Follow-up ]
Adverse events [ Time Frame: all visits after study drug ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open Label, Single-Sequence, Repeat-Dose Study to Investigate the Effects of GSK189075 on the Pharmacokinetics of an Oral Contraceptive Pill When Coadministered to Healthy Female Volunteers

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: GSK189075
Drug: Brevicon

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00504816

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

KG2107494

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP