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

September 29, 2014 updated by: OPKO IP Holdings II, Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Centers
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Research by Design
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Western new England Renal & Transplant Associates
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Twin Cities Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • DCI
      • Cleveland, Ohio, United States, 44109-1998
        • MetroHealth Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Northeast Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Southeast Renal Research Institute
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77099
        • Southwest Houston Research Ltd
    • Wisconsin
      • Delafield, Wisconsin, United States, 53018
        • Purity Dialysis Centers / Nephrology Associates
      • La Crosse, Wisconsin, United States, 54601
        • Gunderson Clinic Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose CTAP101 Capsules
CTAP101 Capsules, 450 mcg dose
Drug: CTAP101 Capsules
Single dose oral administration
Experimental: High Dose CTAP101 Capsules
CTAP101 Capsules, 900 mcg dose
Drug: CTAP101 Capsules
Single dose oral administration
Experimental: CTAP101 Injection
IV injection, 448 mcg dose
Drug: CTAP101 Injection
single IV injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
Time Frame: from 3 to 0 hours prior to dosing until 42 days post dosing
from 3 to 0 hours prior to dosing until 42 days post dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of CTAP101 capsules and injection
Time Frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
From signing of ICF (Day -35) through study completion (Day 42 post dosing)
To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.
Time Frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
From signing of ICF (Day -35) through study completion (Day 42 post dosing)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OPKO IP Holdings II, Inc.

Investigators

  • Study Director: Joel Melnick, MD, OPKO Renal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 23, 2009

First Posted (Estimate)

April 24, 2009

Study Record Updates

Last Update Posted (Estimate)

September 30, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTAP101-CL-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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