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

NCT00501462 | Completed Phase 1

• 1 other identifier: KG2105253
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2; Renal Insufficiency

Keywords

Type 2 Diabetes Mellitus; renal insufficiency

Outcome Measures

Primary Outcomes (1)

• drug & metabolite plasma levels

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

Secondary Outcomes (7)

• urine levels of Glucose & electrolytes, Drug & metabolites

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

• ECG, labs, vital signs, adverse events

  each visit

• Plasma protein binding of GSK189074 and GSK279782

  2 hr

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

  24 hr

• urine glucose excreted.

  6, 12, 24 hours

Study Arms (3)

Mild renal impairmnent

OTHER

Drug: GSK189075

moderate renal impairment

OTHER

Drug: GSK189075

Normal renal function

OTHER

Drug: GSK189075

Interventions

GSK189075 DRUG

single 250 mg dose of drug

Mild renal impairmnent; Normal renal function; moderate renal impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Orlando, Florida, 32809, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37920, United States

Location

GSK Investigational Site

Austin, Texas, 78752, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 16, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 19, 2012

Record last verified: 2011-06

Locations

US (4)