N/A
N=8
Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™
Cystinosis · Nephropathic Cystinosis
Bottom Line
View on ClinicalTrials.gov: NCT01432561 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Cysteamine Absorption: Area Under the Plasma Concentration Curve (AUC) — 3618; 2799; 2457 min*uM — p=.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cysteamine bitartrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cysteamine Absorption: Area Under the Plasma Concentration Curve (AUC) |
3618; 2799; 2457 | .04 sig |
| PRIMARY Peak Plasma Cysteamine Concentration (Cmax) |
26.3; 22.4; 17.2 | .16 |
| PRIMARY Time to Peak Plasma Cysteamine Concentration (Tmax) |
71.2; 106.9; 120 | .30 |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of age and older, with BMI > 18 and 37.6°C) (e.g. a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
-
Data sourced from ClinicalTrials.gov (NCT01432561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.