Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
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To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.
Condition or disease
Drug: SLx-2101Drug: Placebo
Number and cumulative duration of Raynaud's attacks.
Adverse events and changes in vital signs.
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
A Randomized, Double Blind, Placebo-controlled, Cross-over Pilot Study to Examine the Safety, Tolerability and Pharmacodynamic Profile of Repeat Oral Doses of SLx-2101 Once Daily for up to 14 Days in Subjects With Secondary Raynaud's Disease.
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
male and female ages 18 and 65 y.o.
BMI Body weight within a body mass index range of 17 - 30 kg/m2 (inclusive).
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