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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OPKO IP Holdings II, Inc.
• Treatments: Vitamin D

Criteria

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