Last updated: 11/04/2018 08:30:49
A study of the effects of GSK189075 on PK profiles of an oral contraceptive pill when given to healthy female volunteers
GSK study ID
KG2107494
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Oral contraceptive pill (OC) drug levels
Timeframe: over 24h starting on Day 14
blood hormone levels
Timeframe: 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:
Adverse events
Timeframe: all visits after study drug
ECGs, Clinical laboratory tests
Timeframe: screening & follow-up
vital signs
Timeframe: screening;Day 13, Period 1 & 3; Follow-up
Interventions:
Drug: GSK189075
Drug: Brevicon
Enrollment:
22
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus
Product
remogliflozin etabonate
Collaborators
Not applicable
Study date(s)
April 2007 to January 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female
Age
18 - 45 years
Accepts healthy volunteers
Yes
- healthy, non-smoking menstruating female age 18 to 45 years old, inclusive.
- able to take a specific oral contraceptive & KG2107494.
- 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.
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Miramar, Florida, United States, 33025
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-25-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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