The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Capsules, Oral, 2 mg, once daily, 28 days
Capsules, Oral, 10 mg, once daily, 28 days
Capsules, Oral, 20 mg, once daily, 28 days
Farid Marquez, Md
Hialeah, Florida, United States
Capital Clinical Reserch Center
Olympia, Washington, United States
Aurora Advanced Healthcare
Milwaukee, Wisconsin, United States
Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline
Time frame: Within 28 days following dosing
Pharmacokinetics (measuring trough concentrations)
Time frame: On days 7, 14 and 28
Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)
Time frame: Within 28 days following dosing
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Capsules, Oral, 0 mg, once daily, 28 days
Capsules, Oral, ≥ 1500 mg, once daily, 28 days
Local Institution
Blacktown, New South Wales, Australia
Local Institution
Box Hill, Victoria, Australia
Local Institution
Freemantle, Western Australia, Australia
Local Institution
Surrey, British Columbia, Canada
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Bathurst, New Brunswick, Canada
Local Institution
St. John's, Newfoundland and Labrador, Canada
...and 4 more locations