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Type 2 Diabetes MellitusPhase 1NCT00501462

A Comparison Of Study Drug Blood Levels After One Dose Of GSK189075 In Subjects With Normal And Reduced Kidney Function

A Phase 1 study testing GSK189075 in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label study that will measure blood levels of different parts of a drug called GKS189075. People participating in this study will receive a single dose of 250mg GSK189075 by mouth. About 20 people with mild to moderate decrease in renal (kidney) function will be asked to participate in this study. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
GSK189075
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
4 sitesUnited States
Study dates
Jul 2007to Mar 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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A female is eligible to enter and participate in this study if she is of Non-child-bearing potential with a negative pregnancy test at screening or of Childbearing potential, has a negative serum pregnancy test at screening, is not lactating, and agrees to adequate contraception.
  • Satisfactory medical evaluation based upon medical history, medication history, physical examination, and clinical laboratory data obtained at the Screening visit.
  • Body weight > 50 kg. BMI within the range of 19 to 40 kg/m2.
  • Signed and dated written informed consent prior to participation in any protocol-specific procedures, including screening procedures.
  • The subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
  • Additional Inclusion Criteria for Subjects with Renal Insufficiency: Subjects with renal insufficiency must be considered by the investigator to be clinically stable. Subjects must continue to meet this criterion of stable renal function upon check-in into the clinic

Who cannot join

  • History of regular alcohol consumption averaging >7 drinks per week for women or >14 drinks per week for men within 6 months of Screening. One drink is equivalent to 12 g alcohol = 5 ounces (oz; 150 ml) of wine or 12 oz (360 ml) of beer or 1.5 oz (45 ml) of 80 proof distilled spirits.
  • A positive drug or alcohol test at Screening or Check-in.
  • Smokers will be allowed to enrol in the study; however, smoking that interferes with the collection/recording of ongoing study procedures will not be allowed. Smoking status will be recorded in the CRF.
  • The subject has participated in a clinical trial and has received a drug or a new chemical entity 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 study medication for the current study.
  • The subject has donated more than 450mL blood within the 56 day period prior to the first scheduled administration of GSK189075.
  • Known or suspected gastroparesis, gastric surgery within the 6 months prior to screening, or any other gastrointestinal condition that would likely interfere with absorption of GSK189075.
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  • Subjects with clinical laboratory values outside rages as specified in the protocols
  • Any subject with either documented cirrhosis or a history consistent with a diagnosis of cirrhosis.
  • Urinary tract or bladder infection within 4 weeks of the first scheduled administration of study drug.
  • Positive hepatitis B surface antigen, or HIV at Screening. If negative test results have been documented within the last 2 months, it will not be necessary to repeat these tests. Subjects with positive results for hepatitis C antibodies may be eligible if they have normal liver enzymes and no history of hepatitis and are approved by the GSK medical monitor.
  • Any history of myocardial infarction, cardiac syncope.
  • A history of clinically significant cardiac arrhythmias (individual cases to be discussed with the GSK Medical Monitor).
  • A history of unstable angina in the past 6 months.
  • Cardiac conduction abnormalities denoted by ranges specified in the protocol
  • Systolic blood pressure < 80 mmHg or > 180 mmHg
  • Diastolic blood pressure < 60 mmHg or > 100 mmHg
  • Use of prescription or non-prescription drugs (including high dose vitamins, herbal and dietary supplements [including St. John's Wort]) within 7 days prior to administration of the first dose of study medication, unless in the opinion of the investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety. Some allowable exceptions are found in the Permitted Medications section (Section 9.1).
  • Additional Exclusion Criteria for Subjects with Renal Insufficiency
  • Patients on a new drug regimen (defined as starting a new drug or changing dosage regimen of a current drug within 7 days prior to administration of GSK189075). No restrictions will be placed on the use of insulin, 1,25 dihydroxyvitamin D3 (Rocaltrol), erythropoietin, and calcium- or aluminum-containing phosphate binders.
  • Subjects whose current medication therapy is not in agreement with the information provided in Sections 9.1, 9.2, or 9.3 of this protocol.
  • Serum albumin less than 2.5 g/dL.
  • Hemoglobin less than 8.5 g/dL. Additional Exclusion Criteria for Subjects with Normal Renal Function
  • Any clinically relevant abnormality identified on the screening physical or laboratory examination. Any abnormalities of outside the normal reference range at Screening may be repeated once and must be reviewed with the GSK Medical Monitor prior to enrollment of a subject into the study.
  • Hemoglobin or hematocrit below the reference range at Screening

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • GSK Investigational Site

    Austin, Texas, 78752

  • GSK Investigational Site

    Knoxville, Tennessee, 37920

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404

  • GSK Investigational Site

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: An Evaluation of the Pharmacokinetics of a Single Oral Dose of GSK189075 in Patients With Varying Degrees of Renal Insufficiency Compared to Volunteers With Normal Renal Function

This is an open-label study that will measure blood levels of different parts of a drug called GKS189075. People participating in this study will receive a single dose of 250mg GSK189075 by mouth. About 20 people with mild to moderate decrease in renal (kidney) function will be asked to participate in this study. They will be compared to about 20 healthy participants who are close to the same age and body size. People participating in this study will stay at a clinical research unit beginning 2 days before they receive their single dose of GSK189075 and will remain there until approximately one day after receiving the study drug. During this study urine will be collected beginning the day before receiving study drug until the day after, just prior to leaving the clinical research unit. Blood samples will also be collected at various times beginning immediately before until 24 hours after receiving the study drug.

Being tested
GSK189075
Keywords
Type 2 Diabetes Mellitus, renal insufficiency
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK189075Drug

    single 250 mg dose of drug

Study groups in NCT00501462
Study groupRoleWhat they receive
Mild renal impairmnentOtherNot described
Receives: Drug: GSK189075
moderate renal impairmentOtherNot described
Receives: Drug: GSK189075
Normal renal functionOtherNot described
Receives: Drug: GSK189075

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. drug & metabolite plasma levels

    Measured: at 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, & 24 hours after dosing

Secondary outcomes (7)

  1. urine levels of Glucose & electrolytes, Drug & metabolites

    Measured: at 0-6, 6-12 & 12-24 hours after dosing

  2. ECG, labs, vital signs, adverse events

    Measured: each visit

  3. Plasma protein binding of GSK189074 and GSK279782

    Measured: 2 hr

  4. GSK189074 and GSK279782 in 24 hour urine collection and corresponding renal clearance CLr.

    Measured: 24 hr

  5. urine glucose excreted.

    Measured: 6, 12, 24 hours

  6. Urinary creatinine clearance (CLcr).

    Measured: 6, 12, 24 hours

  7. Safety and tolerability parameters, including AEs and clinically relevant changes in vital signs (heart rate and blood pressure), ECGs, urine electrolytes, and clinical laboratory assessments (clinical chemistry, hematology, and urinalysis).

    Measured: 1, 2, 4, 12, 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00501462
Sponsor's protocol ID
KG2105253
Status last verified
Jun 2011
First submitted
13 Jul 2007
Last updated
19 Mar 2012
Results posted
No
Data monitoring committee
No

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 4 sites 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 24 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 4 sites 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?

drug & metabolite plasma levels (time frame: at 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, & 24 hours after dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00501462.

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; AzTrials last refreshed its copy on 7 Nov 2026.

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