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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
• Interventions: Drug: GSK189075; Drug: Brevicon

• Registration Number: NCT00504816
• Lead Sponsor: GlaxoSmithKline

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 available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-18
• Study First Posted: 2007-07-20
• Primary Completion: 2008-01
• Study Completion: 2008-04
• Status Verified: 2011-02
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brevicon	GSK189075	Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.
GSK189075	Brevicon	Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Miramar, Florida, United States