CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Cysteamine bitartratedrug
Likely dose
Cysteamine bitartrate 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01432561
NCT01432561N/ACompleted
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Food-Effect on Bioavailability of Cystagon™ in Normal, Healthy Adults

University of California, San Diego·interventional·Posted Sep 13, 2011·Updated Oct 9, 2013

In Brief

A clinical study evaluating Cysteamine bitartrate for Cystinosis and Nephropathic Cystinosis. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystinosis, Nephropathic Cystinosis
CountriesUnited States
CollaboratorsRaptor Pharmaceuticals Corp.

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.8 years ago

Interventions

Cysteamine bitartratedrug

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