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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504816
• Other study ID #: KG2107494
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2007
• Last updated: May 31, 2012
• Start date: April 2007
• Est. completion date: April 2008

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Miramar	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral contraceptive pill (OC) drug levels		over 24h starting on Day 14	No
Primary	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.	No
Secondary	Adverse events		all visits after study drug	No
Secondary	ECGs, Clinical laboratory tests		screening & follow-up	No
Secondary	vital signs		screening;Day 13, Period 1 & 3; Follow-up	No