Conditions: Healthy
Keywords: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 30
Healthy volunteers: yes

Brief summary:
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.

Detailed description:
This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally administered ST-246 to 30 healthy volunteers ages 18-50 years, randomized to receive either active drug (8 subjects) or placebo (2 subjects) in 1 of 3 dosing groups (250, 400 or 800mg groups). Each dose group of 10 was divided into two cohorts of 5 subjects (4 active and 1 placebo). The first cohort was dosed approximately 4-8 weeks before the second cohort of each dose group. Dose groups completed the study treatment approximately 5 weeks prior to the start of the following dose group. Study procedures included several overnight stays, medical history/exam, laboratory testing done by blood draw, and electrocardiograms.

Arms:
arm 1: 250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days arm 2: Placebo to match ST-246

Interventions: intervention 1: ST-246 intervention 2: Placebo
Intervention descriptions: intervention 1: 250 mg, 400 mg or 800 mg capsules given once daily for 21 days intervention 2: Capsules to match experimental drug

Protocol document: