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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: GSK189075 (Drug); Brevicon (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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: 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

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Primary outcome:

Oral contraceptive pill (OC) drug levels

blood hormone levels

Secondary outcome:

Adverse events

ECGs, Clinical laboratory tests

vital signs

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

GSK Clinical Trials Call Center, Miramar, Florida 33025, United States

Starting date: April 2007
Last updated: December 6, 2007