Type 2 Diabetes MellitusPhase 1NCT00532610
A Study to Compare the Effect on Heart Rhythm of 3 Days of GSK189075, Placebo, or Moxifloxacin in Healthy Adults
A Phase 1 study testing GSK189075 in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3 days at a normal dose and a higher than normal dose compared to placebo or to a single dose of moxifloxacin. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- GSK189075
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating females between 18 and 50 years of age (inclusive), at the time of signing the informed consent form.
- Body mass index (BMI) in the range of 19 to 32 (inclusive)
- Healthy as determined by a qualified physician on the basis of a satisfactory medical evaluation.
- Negative serum pregnancy test for all female subjects.
- Subject has given informed consent to participate in the study as indicated by providing a signed and dated written informed consent form prior to any study procedures.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- Cardiac conduction and repolarization abnormalities described in the protocol.
- Any history of myocardial infarction, syncope, or cardiac arrhythmias or a history of uncontrolled hypertension or unstable heart disease.
- Subjects with a systolic blood pressure outside the range of 90 to 150mmHg or diastolic blood pressure outside the range of 50 to 100mmHg, or a greater than30mmHg change in systolic blood pressure or greater than 20mmHg change in diastolic blood pressure upon orthostatic vital signs.
- Subjects with a personal or family history of QTc prolongation or unexplained cardiac arrest.
- Liver function studies (ALT, AST, Total bilirubin, and alkaline phosphatase above 2 X the upper limit of the normal reference range at Screening and Day -2.
- Has a history of illicit drug use or alcohol abuse within the past year or a positive test for alcohol, cotinine, or drugs of abuse at Screening or prior to the start of dosing in Period 1.
Show all 18Show fewer
- A history of regular alcohol consumption averaging >7 drinks/week for females or >14 drinks/week for males within 6 months of Screening.
- Use of tobacco or nicotine-containing products within 6 months prior to Screening and during the course of the study is prohibited.
- A positive test at Screening for Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV). If documented negative test results have been obtained within the last 2 months, it will not be necessary to repeat these tests.
- Any abnormalities of K+, Ca++ and Mg++
- TSH levels outside the normal range.
- Use of any prescription or non-prescription drugs, vitamins herbal and dietary supplements within fourteen days or 5 half-lives (whichever is longer) prior to the first dose of study drug. Drugs known to inhibit or induce CYP3A4 enzymes are restricted.
- Females of child-bearing potential who are unwilling or unable to use appropriate contraception as defined in the protocol.
- Pregnant or nursing females.
- Females who are using any oral contraception, implants of levonorgestrel, or injectable progesterone.
- Subjects whose participation in the study would result in donation of blood in excess of 500mL within a 56 day period.
- History of hypersensitivity to GSK189075, moxifloxacin, or drugs of these classes, or history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Cross-Over Trial to Investigate the Effect of GSK189075 on Cardiac Repolarization as Compared to Placebo and a Single Dose of Moxifloxacin in Healthy Adult Subjects
This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3 days at a normal dose and a higher than normal dose compared to placebo or to a single dose of moxifloxacin. Treatments are GSK189075 500mg daily for three days plus moxifloxacin placebo on Day 3; GSK189075 4000mg daily for three days plus moxifloxacin placebo on Day 3; placebo tablets daily for three days plus moxifloxacin placebo on Day 3; placebo tablets daily for three days plus Moxifloxacin 400mg on Day 3. Volunteers are blindfolded during dosing. Each volunteer participates in all four treatment periods and will have received each dose combination at study end. Volunteers will stay at the research unit from the day before the first dose of study drug until the day after the last dose of study drug of each period. Safety measures include vital signs, laboratory tests on blood and urine, physical exams and ECGs. Volunteers wear a Holter monitor (a device that records heart rate and rhythm continuously) on days 1 and 3. Study drug levels are assessed by multiple blood draws, most of which occur on day 3.
- Being tested
- GSK189075
- Keywords
- Diabetes,, ECG,, Healthy Volunteers, GSK189075,
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK189075Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous holter monitor & ECG each treatment period:
Measured: Days 1 & 3
Secondary outcomes (5)
Drug plasma levels each treatment period:
Measured: Days 2 & 3
Safety ECG, labs, vital signs & adverse events:
Measured: each treatment period & follow-up
Day 3 change from baseline in QTcB, QTci, QT, and HR.
Blood drug levels of GSK189075 (pro-drug), GSK189074 (active entity), GSK279782 (active metabolite), GSK333081 (metabolite; may be analyzed as indicated by data from the dose escalation study) and moxifloxacin.
12-lead ECGs, vital signs, adverse events, and clinical laboratory tests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionFeb 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 78 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
- NCT00532610
- Sponsor's protocol ID
- KG2107489
- Status last verified
- Feb 2011
- First submitted
- 18 Sep 2007
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Cross-Over Trial to Investigate the Effect of GSK189075 on Cardiac Repolarization as Compared to Placebo and a Single Dose of Moxifloxacin in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00532610
- Acronym / sponsor ID
- KG2107489
- Keywords
- Diabetes,, ECG,, Healthy Volunteers, GSK189075,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 Sep 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.
This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3 days at a normal dose and a higher than normal dose compared to placebo or to a single dose of moxifloxacin. Treatments are GSK189075 500mg daily for three days plus moxifloxacin placebo on Day 3; GSK189075 4000mg daily for three days plus moxifloxacin placebo on Day 3; placebo tablets daily for three days plus moxifloxacin placebo on Day 3; placebo tablets daily for three days plus Moxifloxacin 400mg on Day 3. Volunteers are blindfolded during dosing. Each volunteer participates in all four treatment periods and will have received each dose combination at study end. Volunteers will stay at the research unit from the day before the first dose of study drug until the day after the last dose of study drug of each period. Safety measures include vital signs, laboratory tests on blood and urine, physical exams and ECGs. Volunteers wear a Holter monitor (a device that records heart rate and rhythm continuously) on days 1 and 3. Study drug levels are assessed by multiple blood draws, most of which occur on day 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males or non-pregnant, non-lactating females between 18 and 50 years of age (inclusive), at the time of signing the informed consent form.
- Body mass index (BMI) in the range of 19 to 32 (inclusive)
- Healthy as determined by a qualified physician on the basis of a satisfactory medical evaluation.
- Negative serum pregnancy test for all female subjects.
- Subject has given informed consent to participate in the study as indicated by providing a signed and dated written informed consent form prior to any study procedures.
Key exclusion criteria (18 listed)
- Cardiac conduction and repolarization abnormalities described in the protocol.
- Any history of myocardial infarction, syncope, or cardiac arrhythmias or a history of uncontrolled hypertension or unstable heart disease.
- Subjects with a systolic blood pressure outside the range of 90 to 150mmHg or diastolic blood pressure outside the range of 50 to 100mmHg, or a greater than30mmHg change in systolic blood pressure or greater than 20mmHg change in diastolic blood pressure upon orthostatic vital signs.
- Subjects with a personal or family history of QTc prolongation or unexplained cardiac arrest.
- Liver function studies (ALT, AST, Total bilirubin, and alkaline phosphatase above 2 X the upper limit of the normal reference range at Screening and Day -2.
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 |
|---|---|---|
| GSK189075 | Drug | – |
Primary outcome
Continuous holter monitor & ECG each treatment period:
Time frame: Days 1 & 3
5 secondary outcomes
Drug plasma levels each treatment period:
Time frame: Days 2 & 3
Safety ECG, labs, vital signs & adverse events:
Time frame: each treatment period & follow-up
Day 3 change from baseline in QTcB, QTci, QT, and HR.
Blood drug levels of GSK189075 (pro-drug), GSK189074 (active entity), GSK279782 (active metabolite), GSK333081 (metabolite; may be analyzed as indicated by data from the dose escalation study) and moxifloxacin.
12-lead ECGs, vital signs, adverse events, and clinical laboratory tests.
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 19 Mar 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 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 6 inclusion and 18 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 19 Mar 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?
Continuous holter monitor & ECG each treatment period: (time frame: Days 1 & 3). 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 19 Mar 2012.