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The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00925704
First received: June 19, 2009
Last updated: February 9, 2011
Last verified: February 2011
History of Changes
  Purpose

To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)


Condition Intervention Phase
Healthy
 Drug: Calcitriol
Drug: Lanthanum carbonate + Calcitriol
Drug: Sevelamer carbonate + Calcitriol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase I, Randomized, Open-Label, Three Period Cross-Over Study to Assess the Pharmacokinetics of Oral Calcitriol (ROCALTROL®) in Healthy Volunteers When Administered Alone or When Co-Administered With Lanthanum Carbonate (FOSRENOL®) or Sevelamer Carbonate (RENVELA®)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:
  • Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol [ Time Frame: pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose ] [ Designated as safety issue: No ]
    This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.


Secondary Outcome Measures:
  • Maximum Plasma Concentration (Cmax) for Exogenous Calcitriol [ Time Frame: pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose ] [ Designated as safety issue: No ]
    This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.

  • Time of Maximum Plasma Concentration (Tmax) for Exogenous Calcitriol [ Time Frame: pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose ] [ Designated as safety issue: No ]
    This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.


Enrollment: 41
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calcitriol Drug: Calcitriol
Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
Other Name: Rocaltrol
Experimental: Lanthanum carbonate + calcitriol Drug: Lanthanum carbonate + Calcitriol
Lanthanum carbonate (1000 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
Other Name: Fosrenol + Rocaltrol
Experimental: Sevelamer carbonate + calcitriol Drug: Sevelamer carbonate + Calcitriol
Sevelamer carbonate (2400 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
Other Name: Renvela + Rocaltrol

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Healthy volunteers age 19-45 years inclusive at the time of consent.
  • Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, electrocardiogram (ECG) and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the Investigator.
  • No current or recurrent disease (e.g. cardiovascular, renal, liver, gastrointestinal (GI), malignancy or other conditions) that could affect the action, absorption or disposition of the investigational products utilized in this study, or could affect clinical or laboratory assessments.

Exclusion criteria

  • Current or recurrent disease (eg, cardiovascular, renal, liver, GI, malignancy or other conditions) 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 of physical or psychiatric illness, any medical disorder that could have required treatment or made the subject unlikely to fully complete the study, or any condition that presented undue risk from the investigational product or study procedures.
  • Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 14 days of first dose of investigational product.
  • History of alcohol or other substance abuse within the last year.
  • A positive human immunodeficiency virus antibody screen, Hepatitis B surface antigen or Hepatitis C virus antibody screen.
  • Use of tobacco in any form
  • Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to receiving the first dose of investigational product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925704

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Shire Development LLC
  More Information

Additional Information:
FDA recall information  This link exits the ClinicalTrials.gov site
FDA Medical Product Safety Alerts  This link exits the ClinicalTrials.gov site
FDA-approved label  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Gerald Tremblay, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00925704     History of Changes
Other Study ID Numbers: SPD405-129
Study First Received: June 19, 2009
Results First Received: March 19, 2010
Last Updated: February 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Calcitriol
Sevelamer
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
 Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Chelating Agents

ClinicalTrials.gov processed this record on May 16, 2013