NCT00888069

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: OPKO IP Holdings II, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Kidney Disease
• Secondary Hyperparathyroidism
• Chronic Renal Insufficiency
• Chronic Renal Failure

Interventions

Type	Name	Description
DRUG	CTAP101 Capsules	Single dose oral administration
DRUG	CTAP101 Injection	single IV injection

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2009-04-24
• Last updated: 2014-09-30

Locations

12 sites across 1 country: United States