st-246 has been researched along with Neutropenia* in 1 studies
1 trial(s) available for st-246 and Neutropenia
Article | Year |
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Single-dose safety and pharmacokinetics of ST-246, a novel orthopoxvirus egress inhibitor.
ST-246 is a novel, potent orthopoxvirus egress inhibitor that is being developed to treat pathogenic orthopoxvirus infections of humans. This phase I, double-blind, randomized, placebo-controlled single ascending dose study (first time with humans) was conducted to determine the safety, tolerability, and pharmacokinetics of ST-246 in healthy human volunteers. ST-246 was administered in single oral doses of 500, 1,000, and 2,000 mg to fasting healthy volunteers and 1,000 mg to nonfasting healthy volunteers. ST-246 was generally well tolerated with no serious adverse events, and no subject was withdrawn from the study due to ST-246. The most commonly reported drug-related adverse event was neutropenia, which was found, upon further analysis, not to be treatment related. ST-246 was readily absorbed following oral administration with mean times to maximum concentration from 2 h to 3 h. Absorption was greater in nonfasting volunteers than in fasting volunteers. Administration of ST-246 resulted in exposure levels predicted to be sufficient for inhibiting orthopoxvirus replication compared to exposure levels in nonhuman primates in which ST-246 protected animals from lethal orthopoxvirus infection. Topics: Administration, Oral; Adult; Antiviral Agents; Area Under Curve; Benzamides; Dose-Response Relationship, Drug; Double-Blind Method; Fasting; Humans; Isoindoles; Metabolic Clearance Rate; Neutropenia; Orthopoxvirus | 2008 |