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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: GSK189075
* Drug: Brevicon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Brevicon<br>Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction. | Drug: GSK189075<br>* Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.<br>|
| Experimental: GSK189075<br>Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels. | Drug: Brevicon<br>* Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.<br>* Other names: GSK189075;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy female,, pharmacokinetics,, pharmacodynamics, drug interaction,