Smallpox Clinical Trial
Official title:
A Phase I Randomized, Double-Blind, Crossover, Exploratory Study of the Pharmacokinetics of a Single Oral Dose of Form I Versus Form V Capsules of the Anti-Orthopoxvirus Compound ST-246® in Fed Normal Healthy Volunteers
The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.
This was a Phase I, double-blind, cross-over, single-dose study of the orally administered
anti-orthopoxvirus compound, ST-246, to 12 healthy, fed volunteers between the ages of 18
and 50 years. Subjects were randomized such that 6 subjects received either ST-246 Form I
(monohydrate) followed 10 days later after a wash-out period by Form V (hemihydrate), and 6
subjects received ST-246 Form V followed by Form I, as for the previous group.
Both forms of ST-246 were similar in the way they were manufactured. The only difference
between Form I and Form V may be related to how it dissolves, and this may affect the way
that it is absorbed in the human body. Information about any side-effects that may occur
will also be collected in this study.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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