Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults

NCT00880750 | Completed Phase 1 Results

• 1 other identifier: SPD405-127
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

End stage Renal disease

Outcome Measures

Primary Outcomes (1)

• Urinary Phosphate Excretion 3-Day Average

  Continuous collection over 3 days

Secondary Outcomes (4)

• 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

Study Arms (2)

Lanthanum carbonate granules

EXPERIMENTAL

Lanthanum carbonate granulated formulation crossover to chewable tablet formulation

Drug: Lanthanum carbonate Granule Formulation

Lanthanum carbonate chewable tablets (Fosrenol)

EXPERIMENTAL

Lanthanum carbonate chewable table formulation crossover to granulated formulation

Drug: Lanthanum carbonate Chewable Tablets (Fosrenol)

Interventions

Lanthanum carbonate Granule Formulation 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 granules

Lanthanum carbonate Chewable Tablets (Fosrenol) 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.)

Also known as: Fosrenol

Lanthanum carbonate chewable tablets (Fosrenol)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

West Coast Clinical Trials, LLC

Cypress, California, 90630, United States

Location

Related 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 subjects. Clin Ther. 2012 Jun;34(6):1290-1300.e2. doi: 10.1016/j.clinthera.2012.05.003. Epub 2012 May 31.

  PMID: 22657252 RESULT

Related Links

• FDA recall information

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 14, 2009
• Study Start: January 28, 2009
• Primary Completion: June 22, 2009
• Study Completion: June 22, 2009
• Last Updated: June 11, 2021
• Results First Posted: March 11, 2010

Record last verified: 2021-06

Locations

US (1)