NCT01432561

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

Food-Effect on Bioavailability of Cystagon™ in Normal, Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cystinosis
• Nephropathic Cystinosis

Interventions

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

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-09-13
• Last updated: 2013-10-09
• Results posted: 2013-10-09

Locations

1 site across 1 country: United States