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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00504816

Enrollment

Registered

2007-07-20

Start date

2007-04-30

Completion date

2008-04-30

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus

Keywords

healthy female,, pharmacokinetics,, pharmacodynamics, drug interaction,

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.

Interventions

DRUGGSK189075

Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.

DRUGBrevicon

Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026