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Trial record 11 of 33 for:    CYSTEAMINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01432561
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : October 9, 2013
Last Update Posted : October 9, 2013
Sponsor:
Collaborator:
Raptor Pharmaceuticals Corp.
Information provided by (Responsible Party):
Ranjan Dohil, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE September 9, 2011
First Posted Date  ICMJE September 13, 2011
Results First Submitted Date  ICMJE July 3, 2013
Results First Posted Date  ICMJE October 9, 2013
Last Update Posted Date October 9, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
  • 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 ]
    Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.
  • 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 ]
    Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.
  • 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 ]
    Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2011)
Area under the plasma concentration versus time curve (AUC) of Cystagon [ 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 ]
Change History Complete list of historical versions of study NCT01432561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2011)
Peak Plasma Concentration (Cmax) of Cystagon [ 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™
Official Title  ICMJE Food-Effect on Bioavailability of Cystagon™ in Normal, Healthy Adults
Brief Summary In order to meet FDA standards of safety and efficacy reporting for most new drugs, food-effect bioavailability (the impact that the presence of food in the digestive tract has on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of the rare disease cystinosis that became available in 1994, but there is inadequate knowledge of the food-effect on this drug's bioavailability. This study aims to investigate how food affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Cystinosis
  • Nephropathic Cystinosis
Intervention  ICMJE Drug: Cysteamine bitartrate
500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period.
Other Names:
  • Cystagon
  • Cysteamine
Study Arms  ICMJE Experimental: Cysteamine bitartrate
Cysteamine bitartrate, 500mg once a day, three days.
Intervention: Drug: Cysteamine bitartrate
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: September 12, 2011)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of age and older, with BMI > 18 and < 30.0.
  2. Females of childbearing potential who are sexually active must be willing to use two forms of contraceptive methods throughout the study and for 14days after the last study drug administration.
  3. Minimum weight of 50 kg.
  4. Good health, defined as not having history of any chronic illness and not requiring any regular medication/therapy.
  5. Must swallow tablets on a regular basis.

Exclusion Criteria:

  1. Evidence of Helicobacter pylori infection, presently, or within the last year.
  2. Subjects with known hypersensitivity to cysteamine.
  3. History, currently or within the past 3 months, of the following conditions:

    • Pancreatitis
    • Inflammatory bowel disease
    • Malabsorption
    • Severe liver disease
    • Unstable heart disease, e.g., myocardial infarction, heart failure, arrhythmias.
    • Unstable diabetes mellitus
    • Any bleeding disorder.
    • Zollinger-Ellison syndrome
    • Malignant disease
  4. Subjects whom may be pregnant or have health issues that make it unsafe for them participate, or whose concomitant medical problems preclude them from committing to the study schedule.
  5. Use of an investigational drug within 30 days (or 90 days for biologics) prior to dosing.
  6. Use of prescription medication within 14 days prior to the first dosing;
  7. Use over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing.
  8. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
  9. Hemoglobin <13.5 g/dL (males) and <12.0 g/dL (females) and hematocrit <41.0% (males) and <36.0% (females) at screening.
  10. Breast-feeding subject.
  11. Immunization with a live attenuated vaccine 1 month prior to dosing or planned vaccination during the course of the study.
  12. Presence of fever (body temperature >37.6°C) (e.g. a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01432561
Other Study ID Numbers  ICMJE 111011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ranjan Dohil, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Raptor Pharmaceuticals Corp.
Investigators  ICMJE
Principal Investigator: Ranjan Dohil, M.D. University of California, San Diego
PRS Account University of California, San Diego
Verification Date September 2013

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