Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers

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Shire

Status and phase

Completed
Phase 1

Conditions

Kidney Failure, Chronic

Treatments

Drug: Lanthanum Carbonate
Drug: Sevelamer

Study type

Interventional

Funder types

Industry

Identifiers

NCT00875017
SPD405-128

Details and patient eligibility

About

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).

Enrollment

31 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

31 participants in 4 patient groups

Meal + Lanthanum
Experimental group
Treatment:
Drug: Lanthanum Carbonate
Meal + Sevelamer
Active Comparator group
Treatment:
Drug: Sevelamer
Meal Only
No Intervention group
Fasting
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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