Clinical trial NCT00875017: Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers
Official title: An Open-label, Phase I, One-dose, One-meal, Balance Study Comparing the Absorption of Dietary Phosphorus When Administering FOSRENOL® (Lanthanum Carbonate) or RENVELA® (Sevelamer Carbonate) in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Failure, Chronic
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Primary outcomes:
measure: Net Phosphorous Absorption
timeFrame: 10 hours post-dose
Secondary outcomes:
measure: Net Phosphorous Binding
timeFrame: 10 hours post-dose
measure: Net Calcium Absorption
timeFrame: 10 hours post-dose
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials
state: California
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Martin P, Wang P, Robinson A, Poole L, Dragone J, Smyth M, Pratt R. Comparison of dietary phosphate absorption after single doses of lanthanum carbonate and sevelamer carbonate in healthy volunteers: a balance study. Am J Kidney Dis. 2011 May;57(5):700-6. doi: 10.1053/j.ajkd.2010.11.028. Epub 2011 Feb 26.
citation: Behets GJ, Dams G, Damment SJ, Martin P, De Broe ME, D'Haese PC. Differences in gastrointestinal calcium absorption after the ingestion of calcium-free phosphate binders. Am J Physiol Renal Physiol. 2014 Jan 1;306(1):F61-7. doi: 10.1152/ajprenal.00219.2013. Epub 2013 Nov 6.