| Outcome Measures: |
Primary: Number of participants with adverse events (single and multiple dose studies), * The safety and tolerability of single ascending doses of P11187 in healthy, overweight and/or obese, male and non-child bearing female subjects (Part I). * The safety and tolerability of multiple ascending doses of P11187 in overweight and/or obese, male and non-child bearing female subjects with type 2 diabetes mellitus (Part II)., 12-14 Months|Food Effect, The effect of food on the pharmacokinetics (PK) of P11187 following single oral doses in healthy male subjects, under fed and fasted conditions (Part III)., 12-14 Months | Secondary: Change in Oral Glucose Tolerance Test (OGTT), To determine the effect of single doses of P11187 on pharmacodynamic (PD) parameters (Part I) in the study population defined as follows: * Change in Oral Glucose Tolerance Test (OGTT) variables such as glucose AUC, insulin AUC, C-peptide AUC, glucagon AUC, GLP-1 AUC and GIP AUC., 12-14 month|Area under the plasma concentration (AUC), * To characterize the pharmacokinetics of P11187 following single and multiple doses (Part I and Part II) in the study population as defined. * A non-compartmental PK method will be used to analyze the plasma levels of P11187 on Days 1 (Part I, II \& III) and Day 14 (Part II) * The PK profile will be derived from the P11187 plasma concentration data in both periods i.e. fasted and fed states (Part III)., 12- 14 Month|Change in Intravenous Glucose Tolerance Test, * Multiple doses of P11187 on pharmacodynamic (PD) parameters (Part II) in the study population defined as follows: * Change in Intravenous Glucose Tolerance Test (IVGTT) variables including glucose , insulin and C-peptide will be measured following an IVGTT., 12- 14 Month|Change in the Mixed Meal Tolerance Test, * To determine the effect of multiple doses of P11187 on pharmacodynamic (PD) parameters (Part II) in the study population defined as follows: * Change in the Mixed Meal Tolerance Test (MMTT) variables such as glucose , insulin, C-peptide, glucagon, GLP-1 and GIP., 12- 14 Month|Peak Plasma concentration (Cmax), * To characterize the pharmacokinetics of P11187 following single and multiple doses (Part I and Part II) in the study population as defined. * A non-compartmental PK method will be used to analyze the plasma levels of P11187 on Days 1 (Part I, II \& III) and Day 14 (Part II) * The PK profile will be derived from the P11187 plasma concentration data in both periods i.e. fasted and fed states (Part III)., 12- 14 Month|Time to peak plasma concentration (t-max), * To characterize the pharmacokinetics of P11187 following single and multiple doses (Part I and Part II) in the study population as defined. * A non-compartmental PK method will be used to analyze the plasma levels of P11187 on Days 1 (Part I, II \& III) and Day 14 (Part II) * The PK profile will be derived from the P11187 plasma concentration data in both periods i.e. fasted and fed states (Part III)., 12- 14 Month
|
