| Outcome Measures: |
Primary: Area under the plasma concentration-time curve (AUC) from 0 to the last measurable concentration (AUC 0-t) for albiglutide in session 1 and 2, PK blood samples will be collected for determination of albiglutide plasma concentrations and (AUC 0-t)., Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2|AUC from 0 to infinity (AUC [0-inf]) for albiglutide in session 1 and 2, PK blood samples will be collected for determination of albiglutide plasma concentrations AUC(0-inf)., Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2|Peak plasma concentration (Cmax) for albiglutide in session 1 and 2, PK blood samples will be collected for determination of albiglutide Cmax., Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2 | Secondary: Time to maximal concentration (Tmax) for albiglutide in session 1 and 2, PK blood samples will be collected for determination of albiglutide Tmax., Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2|Clearance (CL/F) for albiglutide in session 1 and 2., PK blood samples will be collected for determination of albiglutide CL/F, Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2|Volume of distribution (V/F) for albiglutide in session 1 and 2, PK blood samples will be collected for determination of albiglutide V/F, Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2|Number of subjects with adverse events (AE) and clinical observations as a measure of safety and tolerability, AE will be collected during the study. Intensity of AE will be captured, Up to 21 weeks|Safety as assessed by 12-lead electrocardiogram (ECG), Single 12-lead ECGs will be obtained at the specified time points during the study using an ECG machine that automatically calculates the heart rate and other measures., Screening, Day -1, Day 4, and Day 35 in both sessions 1 and 2|Safety as assessed by systolic, diastolic blood pressure, and pulse rate measurements, Systolic and diastolic pressure and pulse rate will be measured at specified time point, Up to 21 weeks|Immunogenicity as assessed by enzyme-linked immunosorbent assay (ELISA) and hypersensitivity reactions., Immunogenicity serum samples will be collected at specified time points to assess the presence of anti-drug antibodies through enzyme-linked immunosorbent assay (ELISA) method., Day 1 in both sessions and Day 13 in session 1 and follow-up visit|Half-life (T1/2) for albiglutide in session 1 and 2, PK blood samples will be collected for determination of albiglutide T1/2., Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2.|Composite of hematology parameters as a measure of safety, The following hematology parameters will be measured: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, Reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), MCH Concentration, white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils., Up to 21 weeks|Composite of clinical chemistry parameters as a measure of safety, The following clinical chemistry parameters will be measured: blood urea nitrogen (BUN), creatinine, fasting glucose, uric acid, thyroid-stimulating hormone (TSH), potassium, sodium, calcium, phosphorus, magnesium, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase, gamma glutamyl transferase (GGT), chloride, total and direct bilirubin, total protein, albumin, total carbon dioxide, and fasting triglycerides., Up to 21 weeks|Composite of urinalysis parameters as a measure of safety, The following urinalysis parameters will be measured: specific gravity, power of hydrogen (pH), glucose, protein, blood and ketones by dipstick; microscopic examination (if blood or protein is abnormal), microalbumin, creatinine, albumin/creatinine ratio, blood, leukocyte esterase, and nitrites., Up to 21 Weeks
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