| Outcome Measures: |
Primary: Number of participants with one or more drug related adverse events or serious adverse events, Safety and tolerability of repeat (14 days for normoglycemic healthy subjects (NHS) and 14 days for type 2 diabetes mellitus (T2DM) subjects) and sequential increasing oral doses of LGD-6972 in NHS and subjects withT2DM will be compared to NHS and T2DM subjects receiving placebo., At least 14 days after last dose | Secondary: Pharmacokinetic (PK) profile (area under the concentration curve (AUC) of LGD-6972 after repeat oral doses in NHS and in subjects with T2DM, Steady state PK profile (AUC) of LGD-6972 in NHS and in subjects with T2DM will be characterized and compared., 14 days|Change from baseline in fasting plasma glucose measured 24 hours after first dose and pre-dose Day 14 of treatment with LGD-6972 in NHS, 14 days|Change from baseline in fasting plasma glucagon measured 24 hours after first dose and pre-dose Day 14 of treatment with LGD-6972 in NHS, 14 days|Change from baseline in active and total glucagon-like-peptide (GLP-1) in fasting plasma measured 24 hours after first dose and pre-dose Day 14 of treatment with LGD-6972 in NHS, 14 days|Change from baseline in fasting plasma glucose measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM, 14 days|Change from baseline in fasting plasma glucagon measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM, 14 days|Change from baseline in fasting plasma insulin measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM, 14 days|Change from baseline in fasting plasma active and total GLP-1 measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM, 14 days|Change from baseline in 7-point weighted mean glucose during 14 days of treatment with different doses of LGD-6972 in subjects with T2DM, 14 days|Hemoglobin A1c response during 14 days of treatment with different dosages of LGD-6972 in subjects with T2DM, 14 days|PK profile (maximum concentration (Cmax) of LGD-6972 after repeat oral doses in NHS and in subjects with T2DM, Steady state PK profile (Cmax) of LGD-6972 in NHS and in subjects with T2DM will be characterized and compared., 14 days | Other: Change from baseline in fasting plasma glucose measured during an oral glucose tolerance test (OGTT) on Day 14 of treatment with LGD-6972 at 0.5, 1, 1.5, 2, 3, and 4 hours post-glucose load in one dose group of subjects with T2DM, 14 days|Change from baseline in fasting plasma glucagon measured during an OGTT on Day 14 of treatment with LGD-6972 at 0.5, 1, 1.5, 2, 3, and 4 hours post-glucose load in one dose group of subjects with T2DM, 14 days|Change from baseline in fasting plasma insulin measured during an OGTT on Day 14 of treatment with LGD-6972 at 0.5, 1, 1.5, 2, 3, and 4 hours post-glucose load in one dose group of subjects with T2DM, 14 days|Change from baseline in fasting plasma active and total GLP-1 measured during an OGTT on Day 14 of treatment with LGD-6972 at 0.5, 1, 1.5, 2, 3, and 4 hours post-glucose load in one dose group of subjects with T2DM, 14 days
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| Locations: |
Celerion, Inc, Tempe, Arizona, 85283, United States|Clinical Pharmacology of Miami, Inc, Miami, Florida, 33014, United States|Medpace Clinical Pharmacology, Cincinnati, Ohio, 45227, United States
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