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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
ClinicalTrials.gov Identifier:
NCT00925704
First received: June 19, 2009
Last updated: February 9, 2011
Last verified: February 2011
Results First Received: March 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Calcitriol
Drug: Lanthanum carbonate + Calcitriol
Drug: Sevelamer carbonate + Calcitriol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomly assigned to 1 of 6 treatment sequences which consisted of 3 treatment periods separated by a washout of 7 days. In each of the treatment periods subjects received lanthanum carbonate + calcitriol, sevelamer carbonate + calcitriol or calcitriol alone.

Reporting Groups
  Description
Sequence 1 Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
Sequence 2 Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
Sequence 3 Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
Sequence 4 Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
Sequence 5 Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
Sequence 6 Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention

Participant Flow for 5 periods

Period 1:   First Intervention
    Sequence 1     Sequence 2     Sequence 3     Sequence 4     Sequence 5     Sequence 6  
STARTED     6     7     7     7     7     7  
COMPLETED     6     7     7     6     6     7  
NOT COMPLETED     0     0     0     1     1     0  
Withdrew consent                 0                 0                 0                 1                 1                 0  

Period 2:   Washout
    Sequence 1     Sequence 2     Sequence 3     Sequence 4     Sequence 5     Sequence 6  
STARTED     6     7     7     6     6     7  
COMPLETED     6     7     7     6     6     7  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Second Intervention
    Sequence 1     Sequence 2     Sequence 3     Sequence 4     Sequence 5     Sequence 6  
STARTED     6     7     7     6     6     7  
COMPLETED     5     7     7     6     5     7  
NOT COMPLETED     1     0     0     0     1     0  
Withdrawal by Subject                 1                 0                 0                 0                 1                 0  

Period 4:   Washout
    Sequence 1     Sequence 2     Sequence 3     Sequence 4     Sequence 5     Sequence 6  
STARTED     5     7     7     6     5     7  
COMPLETED     5     7     7     6     5     7  
NOT COMPLETED     0     0     0     0     0     0  

Period 5:   Third Intervention
    Sequence 1     Sequence 2     Sequence 3     Sequence 4     Sequence 5     Sequence 6  
STARTED     5     7     7     6     5     7  
COMPLETED     5     7     7     6     5     6  
NOT COMPLETED     0     0     0     0     0     1  
Withdrew consent                 0                 0                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sequence 1 Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
Sequence 2 Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
Sequence 3 Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
Sequence 4 Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
Sequence 5 Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
Sequence 6 Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
Total Total of all reporting groups

Baseline Measures
    Sequence 1     Sequence 2     Sequence 3     Sequence 4     Sequence 5     Sequence 6     Total  
Number of Participants  
[units: participants]
  6     7     7     7     7     7     41  
Age  
[units: participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     6     7     7     7     7     7     41  
>=65 years     0     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  27.7  ± 8.94     30.0  ± 6.24     30.9  ± 5.52     28.4  ± 7.28     31.0  ± 8.52     30.4  ± 10.41     29.8  ± 7.55  
Gender  
[units: participants]
             
Female     5     3     2     2     4     3     19  
Male     1     4     5     5     3     4     22  
Region of Enrollment  
[units: participants]
             
United States     6     7     7     7     7     7     41  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerald Tremblay, M.D.
Organization: Shire Pharmaceutical
e-mail: gtremblay@shire.com


Publications of Results:

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