Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
- Registration Number
- NCT00528242
- Lead Sponsor
- Response Pharmaceuticals
- Brief Summary
To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.
- Detailed Description
1. Number and cumulative duration of Raynaud's attacks.
2. Adverse events and changes in vital signs.
3. SLx-2101 pharmacokinetic parameters derived after dosing on Day 1 and Day maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-4), time to Cmax (tmax), and accumulation ratio
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
- male and female ages 18 and 65 y.o.
- BMI Body weight within a body mass index range of 17 - 30 kg/m2 (inclusive).
Exclusion Criteria
- Hypersensitivity to the active substance of SLx-2101or to any of the excipients.
- Past or present disease that is judged by the Investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 SLx-2101 SLx-2101 2 Placebo Matching Placebo Dose
- Primary Outcome Measures
Name Time Method Raynaud's condition scores after 14 days of SLx-2101 14 days
- Secondary Outcome Measures
Name Time Method Safety and tolerability 14 days
Trial Locations
- Locations (1)
University des Saarlandes
🇩🇪Homburg, Germany