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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01432561
• Date of registration: 09/09/2011
• Primary sponsor: University of California, San Diego
• Public title: Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™
• Scientific title: Food-Effect on Bioavailability of Cystagon™ in Normal, Healthy Adults
• Date of first enrolment: September 2011
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01432561
• Study type: Interventional
• Study design: Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Ranjan Dohil, M.D.
• Affiliation: University of California, San Diego

Key inclusion & exclusion 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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Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystinosis

Nephropathic Cystinosis

Intervention(s)

Drug: Cysteamine bitartrate

Primary Outcome(s)

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]

Secondary Outcome(s)

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.]

Secondary ID(s)

111011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Raptor Pharmaceuticals Corp.