This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV) and Type 2 Diabetes Mellitus on Metformin (T2DM) This study includes 5 planned cohorts. Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 84
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
142
Anaheim Clinical Trials
Anaheim, California, United States
ProSciento, Inc
Chula Vista, California, United States
QPS Miami Research Associates
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV and T2DM
Time frame: 42 days
Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters
Time frame: 31 days
Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters
Time frame: 31 days
Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters
Time frame: 31 days
Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma
Time frame: 31 days
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