| Outcome Measures: |
Primary: Mean area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast), Vadadustat: Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose. Erythropoiesis-stimulating agent: Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose, Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2|Area under concentration-time curve from time 0 to infinity (AUCinf), Vadadustat: Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose. Erythropoiesis-stimulating agent: Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose, Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2|Maximum observed concentration (Cmax), Vadadustat: Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose. Erythropoiesis-stimulating agent: Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose, Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2|Time to maximum observed concentration (Tmax), Vadadustat: Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose. Erythropoiesis-stimulating agent: Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose, Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2|Terminal half-life (t½), Vadadustat: Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose. Erythropoiesis-stimulating agent: Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose, Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2|Apparent clearance (CL/F) or clearance (CL), Vadadustat: Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose. Erythropoiesis-stimulating agent: Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose, Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2|Apparent volume of distribution (Vd/F) or volume of distribution (Vd), Vadadustat: Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose. Erythropoiesis-stimulating agent: Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose, Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2|Tmax for vadadustat metabolite(s), Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose|AUClast for vadadustat metabolite(s), Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose|AUCinf for vadadustat metabolite(s), Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose|Cmax for vadadustat metabolite(s), Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose|Serum erythropoietin concentration for the erythropoiesis-stimulating agent treatment group, Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose | Secondary: Hepcidin concentration, predose on Days 1, 6, and 10|Serum erythropoietin concentration, predose on Days 1, 6, and 10; post dose on Days 1 and 8|Iron concentration, predose on Days 1, 6, and 10|Ferritin concentration, predose on Days 1, 6, and 10|Total iron-binding capcity, predose on Days 1, 6, and 10|Transferrin saturation, predose on Days 1, 6, and 10|Hemoglobin concentration, post dose on Days 1, 6, and 10|Reticulocyte concentration, predose on Days 1, 6, and 10|Number of participants with any treatment-emergent adverse event, up to Day 40, plus or minus 3 days|Number of participants with clinically significant electrocardiogram findings, up to Day 40, plus or minus 3 days|Number of participants with clinically significant vital sign values, up to Day 40, plus or minus 3 days|Number of participants with clinically significant clinical laboratory values, up to Day 40, plus or minus 3 days
|
