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

A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT

This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).

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

Exclusion Criteria:

• Has nephrotic range proteinuria
• Has liver disease or significant hepatic dysfunction
• Is taking Cytochrome P450 3A4 inhibitors or inducers
• Has adult history of kidney stones and dysphagia
• Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
• Currently on dialysis
• Current serious illness such as cancer, HIV, cardiovascular event or hepatitis