CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
ST-246 Days 1 - 3 +1 moredrug
Likely dose
Not stated in 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/NCT00728689
NCT00728689Phase 1Completed
CompareCT.gov

A Phase I Randomized, Double-Blind, Crossover, Exploratory Study of the Pharmacokinetics of a Single Oral Dose of Form I Versus Form V Capsules of the Anti-Orthopoxvirus Compound ST-246® in Fed Normal Healthy Volunteers

SIGA Technologies·interventional·Posted Aug 6, 2008·Updated Jun 29, 2015

In Brief

A Phase 1 clinical trial evaluating ST-246 Days 1 - 3 and ST-246 Days 11 - 13 for Orthopoxviral Disease and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOrthopoxviral Disease, Smallpox, Monkey Pox
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)

Timeline

Phase 1CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 6, 2008
Enrollment StartAug 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.9 years ago

Interventions

ST-246 Days 1 - 3drug

First Intervention is on Days 1 - 3, and includes 6 patients dosed once orally with ST-246 Form I (Arm 1), and 6 patients dosed once orally with ST-246 Form V (Arm 2).

ST-246 Days 11 - 13drug

Second Intervention is on Days 11 - 13 (after a 3 day post-treatment monitoring and 7 day wash-out period) where the 6 patients previously given ST-246 Form I (Arm 1) are now dosed once orally with ST-246 Form V, and the 6 patients previously given ST-246 Form V (Arm 2) are now dosed once orally with ST-246 Form I.