Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults

NCT ID: NCT00880750

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-28
• Study Completion Date: 2009-06-22

Brief Summary

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lanthanum carbonate granules

Lanthanum carbonate granulated formulation crossover to chewable tablet formulation

Group Type: EXPERIMENTAL

Lanthanum carbonate Granule Formulation

Intervention Type: DRUG

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.)

Lanthanum carbonate chewable tablets (Fosrenol)

Lanthanum carbonate chewable table formulation crossover to granulated formulation

Group Type: EXPERIMENTAL

Lanthanum carbonate Chewable Tablets (Fosrenol)

Intervention Type: DRUG

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.)

Interventions

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.)

Intervention Type: 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.)

Intervention Type: DRUG

Other Intervention Names

Fosrenol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

West Coast Clinical Trials, LLC

Cypress, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22657252 (View on PubMed)

Related Links

http://www.fda.gov/opacom/7alerts.html

FDA recall information

Other Identifiers

SPD405-127

Identifier Type: -

Identifier Source: org_study_id