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Completed

NCT Number: NCT00504816

A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Miramar, Florida, 33025, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK189075

Drug

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

Brevicon

Drug

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

Other names: GSK189075

Primary outcomes

  1. Oral contraceptive pill (OC) drug levels

    Time frame: over 24h starting on Day 14

  2. 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.

Secondary outcomes

  1. Adverse events

    Time frame: all visits after study drug

  2. ECGs, Clinical laboratory tests

    Time frame: screening & follow-up

  3. vital signs

    Time frame: screening;Day 13, Period 1 & 3; Follow-up

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 20, 2007
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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