Overview

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:

Participant gender:

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

Details

Lead Sponsor:

OPKO IP Holdings II, Inc.

Treatments:

Vitamin D