to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM).
The study will be conducted in 2 parts: Part 1 (Single Ascending Dose) This part will include 6 sequential dose cohorts (S1-S6). Part 2 (Multiple Ascending Dose) This part will include 5 sequential dose cohorts (M1-M5). Cohorts M1-M4 will enroll healthy subjects. Cohort M5 will enroll subjects with T2DM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
PPD Development, LP (PPD Clinical Research Unit, Las Vegas)
Las Vegas, Nevada, United States
Incidence, severity of adverse events
Time frame: up to 4 weeks
Maximum Concentration (Cmax) in Plasma
Time frame: up to 4 weeks
Renal Clearance (CLR) in urine
Time frame: up to 2 weeks
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