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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: GSK189075
  • Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
• Drug: Brevicon
  • Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.

Arms, Groups and Cohorts in this Clinical Trial

• Other: Brevicon
  • Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.
• Experimental: GSK189075
  • Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.

Primary Measures

• Oral contraceptive pill (OC) drug levels
  • Time Frame: over 24h starting on Day 14
    Safety Issue?: No
• 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.
    Safety Issue?: No

Secondary Measures

• Adverse events
  • Time Frame: all visits after study drug
    Safety Issue?: No
• ECGs, Clinical laboratory tests
  • Time Frame: screening & follow-up
    Safety Issue?: No
• vital signs
  • Time Frame: screening;Day 13, Period 1 & 3; Follow-up
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00504816

Study ID Number: KG2107494

ClinicalTrials.gov Identifier: NCT00504816

Health Authority: United States: Food and Drug Administration