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A Comparison Of Study Drug Blood Levels After One Dose Of GSK189075 In Subjects With Normal And Reduced Kidney Function | Clinical Trials | Clareo Health

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

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

NCT00501462•GlaxoSmithKline

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•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
+2 more criteria

Exclusion Criteria

•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.
•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.
•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.
+4 more criteria

Locations (4)

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Knoxville, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

Key Dates

Start Date

July 1, 2007

Primary Completion Date

March 1, 2008

Completion Date

March 1, 2008

Last Updated

March 19, 2012

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes MellitusDiabetes Mellitus, Type 2Renal Insufficiency

Interventions

GSK189075

DRUG

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Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

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Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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