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
ClinicalTrials.gov Identifier:
NCT00925704
First received: June 19, 2009
Last updated: February 9, 2011
Last verified: February 2011

June 19, 2009
February 9, 2011
June 2009
July 2009   (final data collection date for primary outcome measure)
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.
The primary outcome measure will be the change from baseline in AUC0-48 for exogenous calcitriol (i.e. Day 1 total calcitriol minus baseline endogenous calcitriol). [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00925704 on ClinicalTrials.gov Archive Site
  • 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.
Secondary outcome measures will be Cmax, AUC0-t and tmax for exogenous calcitriol. Additionally, safety will be assessed by a collection of AEs, vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers
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®)

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Calcitriol
    Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.
    Other Name: Rocaltrol
  • 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
  • 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
  • Active Comparator: Calcitriol
    Intervention: Drug: Calcitriol
  • Experimental: Lanthanum carbonate + calcitriol
    Intervention: Drug: Lanthanum carbonate + Calcitriol
  • Experimental: Sevelamer carbonate + calcitriol
    Intervention: Drug: Sevelamer carbonate + Calcitriol
Pierce D, Hossack S, Poole L, Robinson A, Van Heusen H, Martin P, Smyth M. The effect of sevelamer carbonate and lanthanum carbonate on the pharmacokinetics of oral calcitriol. Nephrol Dial Transplant. 2010 Oct 13; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
19 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00925704
SPD405-129
Not Provided
Gerald Tremblay, M.D., Shire Pharmaceutical
Shire
Not Provided
Not Provided
Shire
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP