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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00501683
First received: July 13, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Drug: Radiolabelled GSK189075
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Mass Balance Study to Investigate the Metabolic Disposition of a 400 mg Single, Oral Dose of GSK189075 in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: November 2006
Intervention Details:
    Drug: Radiolabelled GSK189075
    Other Name: Radiolabelled GSK189075
  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501683

Locations
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00501683     History of Changes
Other Study ID Numbers: KG2105264
Study First Received: July 13, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
metabolite profiling
excretion,
radioactivity,
pharmacokinetic,
mass balance,

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014