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
  Purpose

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.


Condition Intervention
Cystinosis
Nephropathic Cystinosis
Drug: Cysteamine bitartrate

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Food-Effect on Bioavailability of Cystagon™ in Normal, Healthy Adults

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cysteamine bitartrate
Cysteamine bitartrate, 500mg once a day, three days.
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
  • Cysteamine Bitartrate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432561

Locations
United States, California
University of California, San Diego Center for Clinical Research Services (CCR)
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Raptor Pharmaceuticals Corp.
Investigators
Principal Investigator: Ranjan Dohil, M.D. University of California, San Diego
  More Information

Publications:
Responsible Party: Ranjan Dohil, Principal Investigator, 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

Keywords provided by University of California, San Diego:
Lysosomal Storage Diseases
Metabolic Diseases
Metabolism, Inborn Errors

Additional relevant MeSH terms:
Cystinosis
Fanconi Syndrome
Lysosomal Storage Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Renal Tubular Transport, Inborn Errors
Cysteamine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014