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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00504816

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: GSK189075 Drug: Brevicon	Phase I

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Modicon Ethinyl estradiol mixture with norethindrone Norinyl

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Oral contraceptive pill (OC) drug levels [ Time Frame: over 24h starting on Day 14 ] [ Designated as 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: all visits after study drug ] [ Designated as safety issue: No ]
ECGs, Clinical laboratory tests [ Time Frame: screening & follow-up ] [ Designated as safety issue: No ]
vital signs [ Time Frame: screening;Day 13, Period 1 & 3; Follow-up ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	April 2007
Study Completion Date:	April 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Brevicon Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.	Drug: GSK189075 Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
Experimental: GSK189075 Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.	Drug: Brevicon Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK. Other Names: GSK189075 Brevicon

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504816

Locations

United States, Florida
GSK Investigational Site
Miramar, Florida, United States, 33025

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00504816 History of Changes
Other Study ID Numbers:	KG2107494
Study First Received:	July 13, 2007
Last Updated:	October 14, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

healthy female,
drug interaction,
pharmacokinetics,
pharmacodynamics

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Contraceptive Agents
Norinyl
Ethynylestradiol mixture with norethindrone
Contraceptives, Oral

Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on February 12, 2012