NCT00907803

Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246

Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Assess Safety, Tolerability, and PK of the Anti-Orthopoxvirus Compound ST-246 When Administered as a Single Daily Oral Dose for 14 Days in Volunteers in the Fed State

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: SIGA Technologies · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Orthopoxviral Disease

Interventions

Type	Name	Description
DRUG	ST-246 400 mg	Capsules, 400 mg daily for 14 days
DRUG	ST-246 600 mg	Capsules, 600 mg daily for 14 days
DRUG	Placebo	Capsules, once daily for 14 days

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-05-25
• Last updated: 2010-09-21
• Results posted: 2010-08-27

Locations

3 sites across 1 country: United States