EUCTR2009-017882-42-FR
Active, Not Recruiting
Phase 1
A Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic Cystinosis
Raptor Therapeutics Inc.0 sitesJune 14, 2010
DrugsCystagon
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Raptor Therapeutics Inc.
- Status
- Active, Not Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subject with a documented diagnosis of
- •nephropathic cystinosis.
- •2\. Subject must be on a stable dose of Cystagon® sufficient to
- •maintain their white blood cell (WBC) cystine level at \= 1\.0
- •nmol/half\-cystine/mg protein.
- •3\. Subject must be able to swallow their typically administered
- •Cystagon® capsule with the capsule intact.
- •4\. Within the last 6 months, no clinically significant change from
- •normal in liver function tests \[i.e., 1\.5 times ULN for ALT and
- •AST, and/or 1\.5 times ULN for total bilirubin] and renal function
Exclusion Criteria
- •2\. Subjects with current history of the following conditions or any
- •other health issues that make it, in the opinion of the Investigator,
- •unsafe for them to participate:
- •? Inflammatory bowel disease (if currently active) or prior
- •resection of small intestine;
- •? Heart disease (e.g., myocardial infarction, heart failure,
- •unstable arrhythmias, or poorly controlled hypertension)
- •90 days prior to Screening;
- •? Active bleeding disorder 90 days prior to Screening;
- •? History of malignant disease within the last 2 years.
Outcomes
Primary Outcomes
Not specified
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