Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults

A Phase I Pharmacodynamic Equivalence Study Comparing Urinary Phosphate Excretion and Plasma Lanthanum Pharmacokinetics for a Lanthanum Carbonate Granule Formulation and Chewable Tablets Administered to Healthy Adult Subjects

This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: Lanthanum carbonate Granule Formulation; Drug: Lanthanum carbonate Chewable Tablets (Fosrenol)

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 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 18-55 inclusive.
• Subject must be willing to comply with applicable contraceptive requirements of the protocol
• Female subjects must have a negative pregnancy test
• Ability to chew and or swallow doses of the investigational products as prescribed in the protocol.
• Ability to fully comply with all study procedures and restrictions, including consumption of all food provided while a resident in the CRC.

Exclusion Criteria

• 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.
• Clinically significant abnormal serum phosphate levels, outside of normal limits.
• Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 7 days of first dose of investigational product.
• A known history of lactose intolerance or allergy to milk or other foods.
• Clinically significant or multiple allergies as determined by an Investigator.
• History of alcohol or other substance abuse within the last 6 months.
• 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.
• Female subjects who are pregnant (positive pregnancy test), lactating, or less than 90 days post-partum.
• Subjects that have previously been randomized in this study.
• 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 60 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.
• Plasma donation within 28 days prior to the first dose of the 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lanthanum carbonate granules; Lanthanum carbonate granulated formulation crossover to chewable tablet formulation	Drug: Lanthanum carbonate Granule Formulation; 3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.)
Experimental: Lanthanum carbonate chewable tablets (Fosrenol); Lanthanum carbonate chewable table formulation crossover to granulated formulation	Drug: Lanthanum carbonate Chewable Tablets (Fosrenol); 3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.); Other Names: Fosrenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary Phosphate Excretion 3-Day Average	Continuous collection over 3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Urinary Phosphate Excretion on Day 4	Continuous collection on Day 4
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate	3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate	3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate	3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• Pierce D, Hossack S, Robinson A, Zhang P, Martin P. Assessment of pharmacodynamic equivalence and tolerability of lanthanum carbonate oral powder and tablet formulations: a single-center, randomized, open-label, 2-period crossover study in healthy subjects. Clin Ther. 2012 Jun;34(6):1290-1300.e2. doi: 10.1016/j.clinthera.2012.05.003. Epub 2012 May 31.

Helpful Links

• FDA Recall Information

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2009
• Primary Completion (Actual): June 22, 2009
• Study Completion (Actual): June 22, 2009

Study Registration Dates

• First Submitted: April 13, 2009
• First Submitted That Met QC Criteria: April 13, 2009
• First Posted (Estimate): April 14, 2009

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: End stage Renal disease
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: SPD405-127