Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: Lanthanum carbonate Granule Formulation; Lanthanum carbonate Chewable Tablets (Fosrenol)
Intervention description: 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.); 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.)
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: End stage Renal disease

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.
    

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.