Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880750
• Other study ID #: SPD405-127
• Status: Completed
• Phase: Phase 1
• Start date: January 28, 2009
• Est. completion date: June 22, 2009

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 22, 2009
• Est. primary completion date: June 22, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.)
• 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.)

Locations

Country	Name	City	State
United States	West Coast Clinical Trials, LLC	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 subject — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Phosphate Excretion 3-Day Average		Continuous collection over 3 days
Secondary	Urinary Phosphate Excretion on Day 4		Continuous collection on Day 4
Secondary	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
Secondary	Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate		3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Secondary	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

External Links

•   FDA recall information
•   FDA-approved label