A Single Dose Of GSK189075 Taken By Mouth Containing Small Amounts Of Radioactivity Studied In Healthy Male Volunteers

NCT00501683 | Completed Phase 1

• 1 other identifier: KG2105264
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Keywords

metabolite profiling; excretion,; radioactivity,; pharmacokinetic,; mass balance,

Outcome Measures

Primary Outcomes (2)

• Laboratory tests to determine the amount of radiolabelled drug that is found in blood, urine, and feces. Blood samples at Days 1-5.

  at Days 1-5.

• Urine & Fecal collection at Day -1 & days 1-5.

  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

  at each day for up to 10 days

Interventions

Radiolabelled GSK189075 DRUG

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System 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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 16, 2007
• Study Start: November 1, 2006
• Last Updated: June 4, 2012

Record last verified: 2011-02

Locations

US (1)