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

NCT00504816 | Completed Phase 1

• 1 other identifier: KG2107494
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Adverse events

  all visits after study drug

• ECGs, Clinical laboratory tests

  screening & follow-up

• vital signs

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

Study Arms (2)

Brevicon

OTHER

Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.

Drug: GSK189075

GSK189075

EXPERIMENTAL

Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.

Drug: Brevicon

Interventions

GSK189075 DRUG

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

Brevicon

Brevicon DRUG

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

Also known as: GSK189075

GSK189075

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Miramar, Florida, 33025, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 20, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 4, 2012

Record last verified: 2011-02

Locations

US (1)