Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00880750
First received: April 13, 2009
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Drug: Lanthanum carbonate Granule Formulation
Drug: Lanthanum carbonate Chewable Tablets (Fosrenol)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Urinary Phosphate Excretion 3-Day Average [ Time Frame: Continuous collection over 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary Phosphate Excretion on Day 4 [ Time Frame: Continuous collection on Day 4 ] [ Designated as safety issue: No ]
  • Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate [ Time Frame: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate [ Time Frame: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 ] [ Designated as safety issue: No ]
  • Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate [ Time Frame: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Fosrenol

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880750

Locations
United States, California
West Coast Clinical Trials, LLC
Cypress, California, United States, 90630
Sponsors and Collaborators
Shire
  More Information

Additional Information:
Publications:
Responsible Party: Gerald Tremblay, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00880750     History of Changes
Other Study ID Numbers: SPD405-127
Study First Received: April 13, 2009
Results First Received: February 19, 2010
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014