MedTrace Logo

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

NCT00431951 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-07-27

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy

Interventions

DRUG

ST-246

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

DRUG

Placebo

Capsules to match experimental drug

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • SIGA Technologies

    lead INDUSTRY

Principal Investigators

  • Thomas C Marbury, MD · Orlando Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-02-29
Completion
2008-02-29

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 NCT00431951 on ClinicalTrials.gov