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Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™

This study has been completed.
Sponsor:
Collaborator:
Raptor Pharmaceuticals Corp.
Information provided by (Responsible Party):
Ranjan Dohil, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01432561
First received: September 9, 2011
Last updated: September 23, 2013
Last verified: September 2013
Results First Received: July 3, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Cystinosis
Nephropathic Cystinosis
Intervention: Drug: Cysteamine bitartrate

  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
Recruitment period: 09/19/2011 - 11/21/2012 Recruitment Locations: medical centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for liver function and H pylori infection and brief medical history in order to determine if all inclusion and exclusion criteria were met. One enrollee met all inclusion criteria but clinical lab test revealed presence of H Pylori, an exclusion factor. Two enrollees withdrew from the trial prior to assignment due to scheduling conflicts.

Reporting Groups
  Description
Cysteamine Bitartrate

Cysteamine bitartrate, 500mg once a day, three days.

Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period.


Participant Flow:   Overall Study
    Cysteamine Bitartrate  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     0  



  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
Cysteamine Bitartrate

Cysteamine bitartrate, 500mg once a day, three days.

Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period.


Baseline Measures
    Cysteamine Bitartrate  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.9  ± 8.5  
Gender  
[units: participants]
 
Female     3  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures
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1.  Primary:   Cysteamine Absorption: Area Under the Plasma Concentration Curve (AUC)   [ Time Frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose ]

2.  Primary:   Peak Plasma Cysteamine Concentration (Cmax)   [ Time Frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose ]

3.  Primary:   Time to Peak Plasma Cysteamine Concentration (Tmax)   [ Time Frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Ranjan Dohil, P.I.
Organization: University of California San Diego
phone: 619-471-9554
e-mail: rdohil@ucsd.edu


Publications:

Responsible Party: Ranjan Dohil, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01432561     History of Changes
Other Study ID Numbers: 111011
Study First Received: September 9, 2011
Results First Received: July 3, 2013
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board