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

Tracking Information
First Received Date ^ICMJE	June 19, 2009
Last Updated Date	February 9, 2011
Start Date ^ICMJE	June 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 18, 2010)	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.
Original Primary Outcome Measures ^ICMJE (submitted: June 19, 2009)	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 ]
Change History	Complete list of historical versions of study NCT00925704 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 18, 2010)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: June 19, 2009)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers
Official Title ^ICMJE	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®)
Brief Summary	To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Healthy
Intervention ^ICMJE	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
Study Arm (s)	Active Comparator: Calcitriol Intervention: Drug: Calcitriol Experimental: Lanthanum carbonate + calcitriol Intervention: Drug: Lanthanum carbonate + Calcitriol Experimental: Sevelamer carbonate + calcitriol Intervention: Drug: Sevelamer carbonate + Calcitriol
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	41
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	19 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00925704
Other Study ID Numbers ^ICMJE	SPD405-129
Has Data Monitoring Committee	Not Provided
Responsible Party	Gerald Tremblay, M.D., Shire Pharmaceutical
Study Sponsor ^ICMJE	Shire Development LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Shire Development LLC
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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