Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This was a Phase I, double-blind, cross-over, single-dose study of the orally administered anti-orthopoxvirus compound, ST-246, to 12 healthy, fed volunteers between the ages of 18 and 50 years. Subjects were randomized such that 6 subjects received either ST-246 Form I (monohydrate) followed 10 days later after a wash-out period by Form V (hemihydrate), and 6 subjects received ST-246 Form V followed by Form I, as for the previous group.

Both forms of ST-246 were similar in the way they were manufactured. The only difference between Form I and Form V may be related to how it dissolves, and this may affect the way that it is absorbed in the human body. Information about any side-effects that may occur will also be collected in this study. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00728689
Study type Interventional
Source SIGA Technologies
Contact
Status Completed
Phase Phase 1
Start date August 2008
Completion date October 2008

See also
  Status Clinical Trial Phase
Completed NCT05976100 - Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years Phase 1
Completed NCT01540929 - Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
Completed NCT00258947 - Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults Phase 2
Completed NCT00189969 - Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects Phase 1
Terminated NCT00053508 - Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination Phase 2
Completed NCT01317238 - Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers Phase 3
Completed NCT01056770 - Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers Phase 3
Withdrawn NCT00389103 - Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD) Phase 1
Terminated NCT00282581 - Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive Phase 1
Completed NCT00998543 - A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain) Phase 2
Completed NCT00133575 - ACAM 3000 MVA at Harvard Medical School Phase 1/Phase 2
Active, not recruiting NCT00103584 - Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers Phase 1/Phase 2
Completed NCT00050505 - Expanded Dryvax Dilution Study in Previously Vaccinated Adults Phase 2
Completed NCT05846243 - Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years Phase 2/Phase 3
Completed NCT05935917 - Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults Phase 1
Completed NCT00082446 - Combination Study With MVA BN and Dryvax Phase 1
Completed NCT00038987 - Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT Phase 1/Phase 2
Completed NCT05762523 - Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years Phase 1
Completed NCT04971109 - Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Day Phase 3
Completed NCT00646152 - Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study Phase 1