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COMPLETED
NCT00907803
PHASE2

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

Sponsor: SIGA Technologies

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

107

Start Date

2009-06

Completion Date

2010-01

Last Updated

2026-09-11

Healthy Volunteers

Yes

Interventions

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

Locations (3)

Apex Research Institute

Santa Ana, California, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Hawaii Clinical Research Center

Honolulu, Hawaii, United States