Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers

May 27, 2021 updated by: Shire

An Open-label, Phase I, One-dose, One-meal, Balance Study Comparing the Absorption of Dietary Phosphorus When Administering FOSRENOL® (Lanthanum Carbonate) or RENVELA® (Sevelamer Carbonate) in Healthy Adult Volunteers

The purpose of this study is to compare the absorption of dietary phosphorus following a single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate (2400mg).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

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
    • California
      • Cypress, California, United States, 90630
        • West Coast Clinical Trials

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Ability to provide informed consent to participate in the study.
  • Healthy volunteers, age 19-45 inclusive.
  • Subject must be willing to comply with applicable contraceptive requirements of the protocol
  • Female subjects must have a negative pregnancy test
  • Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG and laboratory evaluation.
  • Body Mass Index (BMI) between 20.0 and 29.9kg/m² inclusive.
  • Serum 1.25 dihydroxy vitamin D3 >30pg/mL.
  • Ability to chew or swallow a dose of the investigational products and mannitol solution as prescribed in the protocol.
  • Ability and willingness to fast for up to 24 hours.

Exclusion Criteria

  • Current or recurrent disease that could affect the action, absorption or disposition of the investigational products utilized in this study, or could affect clinical or laboratory assessments.
  • Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures.
  • Significant illness within 2 weeks of the first dose of investigational product.
  • Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 14 days of first dose of investigational product.
  • Known or suspected intolerance or hypersensitivity to the investigational product(s) or mannitol solution, closely related compounds or any of the stated ingredients.
  • History of alcohol or other substance abuse within the last year.
  • A positive screen for alcohol or drugs of abuse.
  • Male subjects who consume more than 21 units of alcohol per week or three units per day. Female subjects who consume more than 14 units of alcohol per week or two units per day.
  • A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody screen.
  • Use of tobacco in any form or other nicotine-containing products in any form. Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the first dose of investigational product.
  • Routine consumption of more than two units of caffeine per day or subjects who experience caffeine withdrawal headaches.
  • Donation of blood or blood products within 60 days prior to receiving the first dose of investigational product.
  • Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrolment in another drug or vaccine clinical study.
  • An inability to follow a standardized diet and/or meal schedule, as required during the study.
  • Substantial changes in eating habits within 30 days prior to receiving the first dose of investigational product, as assessed by the Investigator.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meal + Lanthanum
Drug: Lanthanum Carbonate
1 x 1000mg tablet
Other Names:
  • Fosrenol
Active Comparator: Meal + Sevelamer
Drug: Sevelamer
3 x 800mg tablets
Other Names:
  • Renvela
No Intervention: Meal Only
No Intervention: Fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net Phosphorous Absorption
Time Frame: 10 hours post-dose
Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting).
10 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net Phosphorous Binding
Time Frame: 10 hours post-dose
Net Phosphorous Binding (Lanthanum carbonate period) = Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after meal only. Net Phosphorous Binding (Sevelamer carbonate period) = Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after meal only.
10 hours post-dose
Net Calcium Absorption
Time Frame: 10 hours post-dose
Net Calcium Absorption (Lanthanum carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Lanthanum carbonate + meal minus Rectal effluent calcium after fasting). Net Calcium Absorption (Sevelamer Carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Sevelamer carbonate + meal minus Rectal effluent calcium after fasting). Net Calcium Absorption (Meal only period) = Calcium ingested in meal minus (Rectal effluent calcium after meal only minus Rectal effluent calcium after fasting).
10 hours post-dose

Collaborators and Investigators

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

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

April 20, 2009

Primary Completion (Actual)

June 16, 2009

Study Completion (Actual)

June 16, 2009

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD405-128

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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