Last updated: 11/04/2018 08:30:31
A Single Dose Of GSK189075 Taken By Mouth Containing Small Amounts Of Radioactivity Studied In Healthy Male Volunteers
GSK study ID
KG2105264
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Mass Balance Study to Investigate the Metabolic Disposition of a 400 mg Single, Oral Dose of GSK189075 in Healthy Male Subjects
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Laboratory tests to determine the amount of radiolabelled drug that is found in blood, urine, and feces. Blood samples at Days 1-5.
Timeframe: at Days 1-5.
Urine & Fecal collection at Day -1 & days 1-5.
Timeframe: at Day -1 & days 1-5.
Secondary outcomes:
Adverse events (AEs), vital signs, ECGs and clinical laboratory assessments at each day for up to 10 days
Timeframe: at each day for up to 10 days
Interventions:
Drug: Radiolabelled GSK189075
Enrollment:
8
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus
Product
remogliflozin etabonate
Collaborators
Not applicable
Study date(s)
November 2006 to December 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
30 - 55 years
Accepts healthy volunteers
Yes
- Are a healthy, non-smoking male.
- Are 30 to 55 years old, inclusive.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53704
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-12-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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