A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
MDS Pharma Services
Lincoln, Nebraska, United States
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The primary objective of this study was to evaluate the safety and tolerability of SPI-1005 (ebselen) in healthy subjects. Incidence and severity of Adverse Events were determined in all treatment and placebo groups.
Time frame: 1 month
Pharmacokinetics of SPI-1005 and its major metabolites in healthy subjects
Evaluate the single dose pharmacokinetic profile of SPI-1005 in healthy subjects including Tmax, Cmax, of the parent compound and major metabolites.
Time frame: 24 hours
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