| Outcome Measures: |
Hepatic fat content|Liver enzymes/LFTs|Insulin resistance|Markers of liver injury|Liver fibrosis|Liver stiffness|Controlled attenuation parameter|BMI|Waist circumference|MRI-derived measures of total liver fat index (It will be calculated as the product of liver volume and the liver mean proton-density fat fraction across all liver segments)|MRI-derived measures of total liver volume (Liver volume will be calculated after complete segmentation by summing the liver surface area at each segmented slice, and then multiplying this sum by individual slice thickness, in millilitres [mL])|Lipid and lipoprotein levels|SHBG level|Ovarian function|Free androgen index ( Total testosterone level divided by the sex hormone binding globulin (SHBG) level, and then multiplying by a constant, usually 100. The concentrations of testosterone and SHBG are normally measured in nanomols per liter.|Peak Plasma concentration [Cmax] (For Single Dose)|Time to reach peak Plasma concentration [Tmax] (For Single Dose)|Area under Plasma concentration vs. time curve till the last time point [AUC0-t] (For Single Dose)|Area under Plasma concentration vs. time curve extrapolated to the infinity (AUC0-???) after first dose (For Single Dose)|Area under plasma concentration vs. time curve in a 24 h dosing interval (AUCtau) after first dose (For Single Dose)|Elimination rate constant [Kel] (For Single Dose)|Elimination half-life [tHalf] (For Single Dose)|Apparent Volume of distribution [Vd/F] (For Single Dose)|Apparent Clearance [CL/F] (For Single Dose)|Peak Plasma concentration [Cmax,ss] (For Multiple Dose)|Time to reach peak Plasma concentration [Tmax,ss] (For Multiple Dose)|Area under plasma concentration vs. time curve in a 24 h dosing interval (AUCtau) after last dose (For Multiple Dose)|Elimination rate constant [Kel,ss] (For Multiple Dose)|Elimination half-life [thalf,ss] (For Multiple Dose)|Apparent Volume of distribution [Vd/F,ss] (For Multiple Dose)|Apparent Clearance [CL/F,ss] (For Multiple Dose)|Minimal or Trough plasma concentration [Cmin] (For Multiple Dose)|Fluctuation index (For Multiple Dose)|Accumulation index calculated as a ratio of AUCtau (last dose)/AUCtau (first dose) (For Multiple Dose)
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| Locations: |
Dr.Anita Kohli, Chandler, Arizona, United States|Dr.Robert Allen Jenders, Panorama City, California, United States|University of California, San Francisco, San Francisco, California, United States|Dr.Melanie Cree Green, Aurora, Colorado, United States|Dr. Yaneicy Gonzalez Rojas, Miami, Florida, United States|Indiana University Health, Indianapolis, Indiana, United States|Dr. KATHRYN JEAN LUCAS, Morehead City, North Carolina, United States|Dr. Nicole Loo, San Antonio, Texas, United States|Dr. Mark Kipnes, San Antonio, Texas, United States|Centro de Investigaci??n Medico Biol??gica y Terapia Avanzada SC (CIMBYTA), Guadalajara, Jalisco, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo Le??n, Mexico|UBAM Unidad Biom??dica Avanzada Monterrey, Monterrey, Nuevo Le??n, Mexico|Centro para el Desarrollo de la Medicina y de Asistencia M??dica Especializada S.C., Culiac??n, Sinaloa, Mexico|Medical Care and Research S.A. de C.V., M??rida, Yucat??n, Mexico|CEMDEC S.A. de C.V. (Centero Mexicana Desarrollo de Estudios Clinicos), Ciudad de mexico, Mexico
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