Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: Lanthanum Carbonate; Sevelamer
Intervention description: 1 x 1000mg tablet; 3 x 800mg tablets
Intervention MeSH terms: Sevelamer
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the absorption of dietary phosphorus following a
      single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate
      (2400mg).
    

Eligibility criteria:

        Inclusion Criteria

          -  Ability to provide informed consent to participate in the study.

          -  Healthy volunteers, age 19-45 inclusive.

          -  Subject must be willing to comply with applicable contraceptive requirements of the
             protocol

          -  Female subjects must have a negative pregnancy test

          -  Satisfactory medical assessment with no clinically significant or relevant
             abnormalities in medical history, physical examination, vital signs, ECG and
             laboratory evaluation.

          -  Body Mass Index (BMI) between 20.0 and 29.9kg/m² inclusive.

          -  Serum 1.25 dihydroxy vitamin D3 >30pg/mL.

          -  Ability to chew or swallow a dose of the investigational products and mannitol
             solution as prescribed in the protocol.

          -  Ability and willingness to fast for up to 24 hours.

        Exclusion Criteria

          -  Current or recurrent disease that could affect the action, absorption or disposition
             of the investigational products utilized in this study, or could affect clinical or
             laboratory assessments.

          -  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.

          -  Significant illness within 2 weeks of the first dose of investigational product.

          -  Current use of any medication with the exception of hormonal replacement therapy or
             hormonal contraceptives within 14 days of first dose of investigational product.

          -  Known or suspected intolerance or hypersensitivity to the investigational product(s)
             or mannitol solution, closely related compounds or any of the stated ingredients.

          -  History of alcohol or other substance abuse within the last year.

          -  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.

          -  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 30 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.

          -  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.

          -  An inability to follow a standardized diet and/or meal schedule, as required during
             the study.

          -  Substantial changes in eating habits within 30 days prior to receiving the first dose
             of investigational product, as assessed by the Investigator.