Type 2 Diabetes MellitusPhase 1NCT00501683
A Single Dose Of GSK189075 Taken By Mouth Containing Small Amounts Of Radioactivity Studied In Healthy Male Volunteers
A Phase 1 study testing Radiolabelled 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 look at the relative amounts of GSK189075 that are found in samples of blood, urine, and feces of healthy male volunteers. Results of the study will be used to understand how the drug is converted in the body and how it is eliminated. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- Radiolabelled GSK189075
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are a healthy, non-smoking male.
- Are 30 to 55 years old, inclusive.
- Have a Body Mass Index (BMI) between 19-30 kg/m2, inclusive; and a body weight >110 lbs.
- Have a history of regular bowel movements (at least 4 times per week).
- Are willing and able to provide written informed consent before the start of any study-related procedures.
Who cannot join
- Have any significant laboratory abnormality or history of liver or kidney disease.
- Have any significant abnormality in your electrocardiograms (ECG) which are recordings of your heart rhythm.
- Have a current condition(s) that alters normal gastrointestinal (GI) function (such as constipation or removal of your gallbladder).
- Have an illness that requires treatment by a physician in the 30 days before screening or a fever and illness in the 5 days before dosing.
- Have blood pressure that is outside the normal range.
- Have a resting pulse rate that is outside the normal range.
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- Have had surgery within 3 months before screening, unless approved by the GSK medical monitor.
- Have a drug allergy which the investigator feels would make it unsafe for you to participate in the study.
- Have a history of or current abuse of alcohol.
- Have a history of or current use of illicit drugs, or a positive drug screen.
- Have used tobacco products within 3 months prior to screening or have a positive cotinine test result.
- Are unable to refrain from foods or beverages containing coffee, tea, or chocolate for 72 hours before dosing with study drug and until 24 hours after dose.
- Have a positive test for human immunodeficiency virus (HIV) antibody or hepatitis B surface antigen or hepatitis C antibody.
- Have taken prescription or non-prescription drugs, including vitamins, herbal products, or plant-derived supplements (including St John's Wort) within 14 days (or less than 5 half-lives) before the first dose of study medication, unless approved by the GSK medical monitor
- Have participated in an investigational drug study within the 30 days before screening, or participated within the last 12 months in a study with another radio labeled drug product.
- Have a total radiation exposure from the previous 3-year period that is over 10 mSv (either from your work or through participation in other research studies). Clinical (therapeutic or diagnostic) exposure will not be included.
- Have donated blood (450 mL or more) within the previous 12 weeks.
- Are in an occupation which requires monitoring for radiation exposure, nuclear medicine procedures or have had excessive x-rays within the past 12 months.
- Are not able to follow the study directions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mass Balance Study to Investigate the Metabolic Disposition of a 400 mg Single, Oral Dose of GSK189075 in Healthy Male Subjects
This study will look at the relative amounts of GSK189075 that are found in samples of blood, urine, and feces of healthy male volunteers. Results of the study will be used to understand how the drug is converted in the body and how it is eliminated.
- Being tested
- Radiolabelled GSK189075
- Keywords
- metabolite profiling, excretion,, radioactivity,, pharmacokinetic,, mass balance,
- 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.
Radiolabelled GSK189075Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory tests to determine the amount of radiolabelled drug that is found in blood, urine, and feces. Blood samples at Days 1-5.
Measured: at Days 1-5.
Urine & Fecal collection at Day -1 & days 1-5.
Measured: at Day -1 & days 1-5.
Secondary outcomes (1)
Adverse events (AEs), vital signs, ECGs and clinical laboratory assessments at each day for up to 10 days
Measured: at each day for up to 10 days
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 startNov 2006
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
- 8 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
- NCT00501683
- Sponsor's protocol ID
- KG2105264
- 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 Mass Balance Study to Investigate the Metabolic Disposition of a 400 mg Single, Oral Dose of GSK189075 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00501683
- Acronym / sponsor ID
- KG2105264
- Keywords
- metabolite profiling, excretion,, radioactivity,, pharmacokinetic,, mass balance,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- 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 look at the relative amounts of GSK189075 that are found in samples of blood, urine, and feces of healthy male volunteers. Results of the study will be used to understand how the drug is converted in the body and how it is eliminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Are a healthy, non-smoking male.
- Are 30 to 55 years old, inclusive.
- Have a Body Mass Index (BMI) between 19-30 kg/m2, inclusive; and a body weight >110 lbs.
- Have a history of regular bowel movements (at least 4 times per week).
- Are willing and able to provide written informed consent before the start of any study-related procedures.
Key exclusion criteria (19 listed)
- Have any significant laboratory abnormality or history of liver or kidney disease.
- Have any significant abnormality in your electrocardiograms (ECG) which are recordings of your heart rhythm.
- Have a current condition(s) that alters normal gastrointestinal (GI) function (such as constipation or removal of your gallbladder).
- Have an illness that requires treatment by a physician in the 30 days before screening or a fever and illness in the 5 days before dosing.
- Have blood pressure that is outside the normal range.
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 |
|---|---|---|
| Radiolabelled GSK189075 | Drug | – |
Primary outcome
Laboratory tests to determine the amount of radiolabelled drug that is found in blood, urine, and feces. Blood samples at Days 1-5.
Time frame: at Days 1-5.
Urine & Fecal collection at Day -1 & days 1-5.
Time frame: at Day -1 & days 1-5.
1 secondary outcome
Adverse events (AEs), vital signs, ECGs and clinical laboratory assessments at each day for up to 10 days
Time frame: at each day for up to 10 days
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 Radiolabelled 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 5 inclusion and 19 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?
Laboratory tests to determine the amount of radiolabelled drug that is found in blood, urine, and feces. Blood samples at Days 1-5. (time frame: at Days 1-5.). 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.