Conditions: Cystinosis Nephropathic Cystinosis
Keywords: Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: yes

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:

Arms:
arm 1: Cysteamine bitartrate, 500mg once a day, three days.

Interventions: intervention 1: Cysteamine bitartrate
Intervention descriptions: intervention 1: 500 mg total, single dose taken orally on visits 2, 3 \& 4 which must occur within a 14 day period.

Protocol document: