Type 2 Diabetes MellitusPhase 1NCT00501930
A Study to Evaluate and Study Drug Levels in Blood Plasma When Giving High Doses of GSK189075 to Healthy Volunteers
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 will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer urine and blood. 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to not given
- 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 and non-pregnant females as determined by a physician on the basis of medical history (including family history of heart disease), physical examination, and clinical laboratory tests.
- written consent given
- agreement to follow specific requirements of birth control during participation.
Who cannot join
- history of drug or alcohol abuse within one year of the study screening.
- use of tobacco or nicotine-containing products with 6 months prior to the study screening.
- use of any prescription or non-prescription drugs, vitamins, herbal, and dietary supplements within 14 days of the start of the study.
- blood donation within 56 days before the start of the study
- receiving other investigational drugs or participating in other research trials within 30 days of the start of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Repeat Dose, Dose Escalation Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Supratherapeutic Doses of GSK189075 Administered for 3 Days in Healthy Volunteers
This study will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo). Volunteers will not know which of the three doses they are receiving. In each period, volunteers will dose every morning for three straight days. Before and after dosing, blood pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs will be taken to assess safety. Volunteers will also be asked to provide information should they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in the blood will be assessed by multiple blood draws, most of these will follow the third dose in each period. Depending on the results from the preceding periods, a fourth period may be added to the study to assess another dose level. The fourth period, if this is to occur, will be the same design as the other three periods, and the dose received will be less than 4000mg.
- Being tested
- GSK189075
- Keywords
- Dose Escalation;, Supratherapeutic;, GSK189075;, Diabetes
- 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.
Clinical laboratory tests, ECGs, adverse events
Measured: screening, Day -1 - 3 all periods, follow up
Secondary outcomes (2)
blood plasma levels of GSK189075
Measured: Day 3
clinical lab tests
Measured: each day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startApr 2007
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
- 12 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
- NCT00501930
- Sponsor's protocol ID
- KG2109799
- 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
- A Randomized, Placebo-Controlled, Double-Blind, Repeat Dose, Dose Escalation Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Supratherapeutic Doses of GSK189075 Administered for 3 Days in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00501930
- Acronym / sponsor ID
- KG2109799
- Keywords
- Dose Escalation;, Supratherapeutic;, GSK189075;, Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- First posted
- 16 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.
This study will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo). Volunteers will not know which of the three doses they are receiving. In each period, volunteers will dose every morning for three straight days. Before and after dosing, blood pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs will be taken to assess safety. Volunteers will also be asked to provide information should they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in the blood will be assessed by multiple blood draws, most of these will follow the third dose in each period. Depending on the results from the preceding periods, a fourth period may be added to the study to assess another dose level. The fourth period, if this is to occur, will be the same design as the other three periods, and the dose received will be less than 4000mg.
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 (3 listed)
- Healthy males and non-pregnant females as determined by a physician on the basis of medical history (including family history of heart disease), physical examination, and clinical laboratory tests.
- written consent given
- agreement to follow specific requirements of birth control during participation.
Key exclusion criteria (5 listed)
- history of drug or alcohol abuse within one year of the study screening.
- use of tobacco or nicotine-containing products with 6 months prior to the study screening.
- use of any prescription or non-prescription drugs, vitamins, herbal, and dietary supplements within 14 days of the start of the study.
- blood donation within 56 days before the start of the study
- receiving other investigational drugs or participating in other research trials within 30 days of the start of this study.
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
Clinical laboratory tests, ECGs, adverse events
Time frame: screening, Day -1 - 3 all periods, follow up
2 secondary outcomes
blood plasma levels of GSK189075
Time frame: Day 3
clinical lab tests
Time frame: each day
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 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 3 inclusion and 5 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?
Clinical laboratory tests, ECGs, adverse events (time frame: screening, Day -1 - 3 all periods, follow up). 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.