Type 2 Diabetes MellitusPhase 1NCT00504816
A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
A Phase 1 study testing GSK189075 and Brevicon in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- GSK189075 and Brevicon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- GSK189075, Brevicon
- Keywords
- healthy female,, pharmacokinetics,, pharmacodynamics, drug interaction,
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK189075Drug
Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
BreviconDrug
Also called GSK189075
Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
| Study group | Role | What they receive |
|---|---|---|
| Brevicon | Other | Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction. Receives: Drug: GSK189075 |
| GSK189075 | Experimental | Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels. Receives: Drug: Brevicon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral contraceptive pill (OC) drug levels
Measured: over 24h starting on Day 14
blood hormone levels
Measured: 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
Measured: all visits after study drug
ECGs, Clinical laboratory tests
Measured: screening & follow-up
vital signs
Measured: screening;Day 13, Period 1 & 3; Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504816
- Sponsor's protocol ID
- KG2107494
- Status last verified
- Feb 2011
- First submitted
- 13 Jul 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00504816
- Acronym / sponsor ID
- KG2107494
- Keywords
- healthy female,, pharmacokinetics,, pharmacodynamics, drug interaction,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brevicon | Other | Drug: GSK189075Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction. |
| GSK189075 | Experimental | Drug: BreviconGiven in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK189075Given with Brevicon to determine any effects of GSK189075 on Brevicon PK. | Drug | Brevicon |
| BreviconAlso: GSK189075Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK. | Drug | GSK189075 |
Primary outcome
Oral contraceptive pill (OC) drug levels
Time frame: over 24h starting on Day 14
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.
3 secondary outcomes
Adverse events
Time frame: all visits after study drug
ECGs, Clinical laboratory tests
Time frame: screening & follow-up
vital signs
Time frame: screening;Day 13, Period 1 & 3; Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK189075 and Brevicon in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral contraceptive pill (OC) drug levels (time frame: over 24h starting on Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.