Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers

Study acronym: SIGA-246-002
StatusCompleted
PhasePhase 1
Started

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Record History

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  1. 3 versions Re-verified since Sep 15, 2010, no change to tracked fieldsv11-v13
  2. Primary endpoint revised
    • Secondary endpoints: details revised at 3 of 12 entries
    v10
  3. Results first posted: May 7, 2010v9 Show 6 more changesShow less
    • Primary endpoints: 3 to 1
    • Interventions: ST-246 (Drug) to Placebo (Drug), ST-246 (Drug)
    • Secondary endpoints: 2 to 12
    • Study description expanded, about 12 words
    • Study title revised
    • Study arms: 0 to 2
  4. Re-verified, no change to tracked fieldsv8
  5. Trial status: Active, Not Recruiting to Completed
    • Primary completion date: Feb 2008
    • Study completion date changed from estimate of Oct 2007 to Feb 2008
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary endpoints revised (3)
    • Interventions: SIGA-246 (Drug) to ST-246 (Drug)
    • Study description revised
    • Eligibility criteria expanded, about 2 words
    v4
  4. Study completion date: Jul 2007 to Oct 2007
    • Study description revised
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00431951
Lead Sponsor SIGA Technologies
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Healthy
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov