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Phase I Trial of an Investigational Small Pox Medication

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
SIGA Technologies
ClinicalTrials.gov Identifier:
NCT00728689
First received: August 1, 2008
Last updated: September 15, 2010
Last verified: September 2010
History of Changes
Results First Received: June 10, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Orthopoxviral Disease
Smallpox
Monkey Pox
Interventions: Other: Days 1 - 3
Other: Days 11 - 13

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study period was approximately 2 weeks (from August 26, 2008 to September 8, 2008), plus a 30-day post-treatment follow up. The study was conducted at a Phase I Study Unit of a Clinical Research Center in Orlando, FL.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants needed to meet strict entry criteria. Sixty-three subjects were screened to randomize 12 subjects into the study.

Reporting Groups
  Description
ST-246 Form I Followed by Form V Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
ST-246 Form V Followed by Form I Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.

Participant Flow for 3 periods

 Period 1:   First Intervention (Days 1 - 3)
    ST-246 Form I Followed by Form V     ST-246 Form V Followed by Form I  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  

Period 2:   Washout Period (Days 4 - 10)
    ST-246 Form I Followed by Form V     ST-246 Form V Followed by Form I  
STARTED     6     6  
COMPLETED     5 [1]   6  
NOT COMPLETED     1     0  
Death in family                 1                 0  
[1] Death in family during the Washout period. Completed First Intervention period with ST-246 Form I.

Period 3:   Second Intervention (Days 11 - 13)
    ST-246 Form I Followed by Form V     ST-246 Form V Followed by Form I  
STARTED     5     6  
COMPLETED     5     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
ST-246 Form I Followed by Form V Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
ST-246 Form V Followed by Form I Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
Total Total of all reporting groups

Baseline Measures
    ST-246 Form I Followed by Form V     ST-246 Form V Followed by Form I     Total  
Number of Participants  
[units: participants]
 		  6     6     12  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  34.7  ± 8     34.8  ± 9.4     34.8  ± 8.3  
Gender  
[units: participants]
 		     
Female     4     6     10  
Male     2     0     2  
Region of Enrollment  
[units: participants]
 		     
United States     6     6     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: t½   [ Time Frame: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs ]
  Show Outcome Measure 1

2.  Primary:   Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-τ   [ Time Frame: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs ]
  Show Outcome Measure 2

3.  Primary:   Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-∞   [ Time Frame: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs ]
  Show Outcome Measure 3

4.  Primary:   Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Cmax   [ Time Frame: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs ]
  Show Outcome Measure 4

5.  Primary:   Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Tmax   [ Time Frame: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs ]
  Show Outcome Measure 5

6.  Secondary:   Number of Study Participants Who Tolerated a Single Dose of ST-246 Form I vs. Form V as Determined by No Clinically Significant Changes in Safety Parameters   [ Time Frame: 4 weeks ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Annie Frimm, Vice President, Regulatory Affairs
Organization: Siga Technologies, Inc.
phone: 951-303-8797
e-mail: afrimm@siga.com


No publications provided


Responsible Party: Dennis Hruby, SIGA Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00728689     History of Changes
Other Study ID Numbers: SIGA-246-005, DMID 08-0014
Study First Received: August 1, 2008
Results First Received: June 10, 2009
Last Updated: September 15, 2010
Health Authority: United States: Food and Drug Administration