CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
ST-246 +1 moredrug
Likely dose
ST-246 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00431951
NCT00431951Phase 1Completed
CompareCT.gov

Double-blind, Randomized, Placebo-controlled, Escalating, Multiple-dose, Phase I Trial to Assess Safety, Tolerability and Pharmacokinetics of ST-246 Administered as a Single Daily Dose for 21 Days in Healthy, Non-fasted Volunteers

SIGA Technologies·interventional·Posted Feb 6, 2007·Updated Jul 27, 2017

In Brief

A Phase 1 clinical trial evaluating ST-246 and Placebo for Healthy. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2007
Enrollment StartFeb 1, 2007
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.4 years ago

Interventions

ST-246drug

250 mg, 400 mg or 800 mg capsules given once daily for 21 days

Placebodrug

Capsules to match experimental drug