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

NCT00907803 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2010-09-21

Study results available
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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.

Conditions

  • Orthopoxviral Disease

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • SIGA Technologies

    lead INDUSTRY

Principal Investigators

  • Thomas Marbury, MD · Orlando Clinical Research Center

  • Erik Ross, MD · Apex Research Institute

  • Jon Ruckle, MD · Hawaii Clinical Research Center

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00907803 on ClinicalTrials.gov