Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects

Inclusion Criteria

• •Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2
• •Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
• •Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
• •Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
• •Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
• •Serum 25-hydroxyvitamin D level greater than 15 ng/mL and lower than 30 ng/mL
• •Hemoglobin level greater than or equal to 10 g/dL