Conditions: Orthopoxviral Disease
Keywords: Orthopoxvirus Smallpox This is a safety study only ST-246 is being studied for treatment of Orthopoxviruses
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 107
Healthy volunteers: yes

Brief summary:
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.

Detailed description:
This study is a Phase II, double-blind, randomized, placebo-controlled, multi-center (3 sites) trial to assess the safety, tolerability, and pharmacokinetics of 400 mg and 600 mg Form I ST-246 when administered as a single daily oral dose for 14 days to 107 healthy, fed volunteers between 18 and 74 years of age. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms.

Arms:
arm 1: ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days arm 2: ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days arm 3: Matching Placebo capsules, Orally Once Daily for 14 days

Interventions: intervention 1: ST-246 400 mg intervention 2: ST-246 600 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Capsules, 400 mg daily for 14 days intervention 2: Capsules, 600 mg daily for 14 days intervention 3: Capsules, once daily for 14 days

Protocol document: