Text Size

Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246 (246-Safety)

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
SIGA Technologies
ClinicalTrials.gov Identifier:
NCT00907803
First received: May 21, 2009
Last updated: September 15, 2010
Last verified: September 2010
History of Changes
Results First Received: July 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Orthopoxviral Disease
Interventions: Drug: ST-246 400 mg
Drug: ST-246 600 mg
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at three sites: Apex Research Institute, Santa Ana, CA, Hawaii Clinical Research Center, Honolulu, HI, and Orlando Clinical Research Center, Orlando, FL. The study was conducted in male and female volunteers ages 18 - 75 years inclusive from the sites' databases.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following an up to 14-day Screening Period, eligible subjects were randomly assigned to receive either ST-246 400 mg (n=45) or ST-246 600 mg (n=46) or placebo (n=16). Treatment was orally administered after a light meal over a 14-day Treatment Period. There was a 28-day Follow-up Period.

Reporting Groups
  Description
ST-246 400 mg 400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
ST-246 600 mg 600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
Placebo Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.

Participant Flow:   Overall Study
    ST-246 400 mg     ST-246 600 mg     Placebo  
STARTED     45     46     16  
COMPLETED     42     43     16  
NOT COMPLETED     3     3     0  
Withdrawal of consent - long commute                 1                 0                 0  
Adverse Event                 2                 0                 0  
Withdrawal by Subject                 0                 1                 0  
Lost to Follow-up                 0                 1                 0  
Protocol Violation                 0                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
ST-246 400 mg 400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
ST-246 600 mg 600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
Placebo Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
Total Total of all reporting groups

Baseline Measures
    ST-246 400 mg     ST-246 600 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  45     46     16     107  
Age  
[units: participants]
 		       
<=18 years     2     0     0     2  
Between 18 and 65 years     41     40     13     94  
>=65 years     2     6     3     11  
Age  
[units: years]
Mean ± Standard Deviation 		  41.3  ± 15.22     43.7  ± 15.81     42.5  ± 17.03     42.5  ± 15.64  
Gender  
[units: participants]
 		       
Female     27     22     9     58  
Male     18     24     7     49  
Region of Enrollment  
[units: participants]
 		       
United States     45     46     16     107  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.   [ Time Frame: Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose ]
  Show Outcome Measure 1

2.  Secondary:   Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax   [ Time Frame: Day 1 post-dose ]
  Show Outcome Measure 2

3.  Secondary:   Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax   [ Time Frame: Day 14 post-dose ]
  Show Outcome Measure 3

4.  Secondary:   Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax   [ Time Frame: Day 1 post-dose ]
  Show Outcome Measure 4

5.  Secondary:   Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax   [ Time Frame: Day 14 post-dose ]
  Show Outcome Measure 5

6.  Secondary:   Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau   [ Time Frame: Day 1 post-dose ]
  Show Outcome Measure 6

7.  Secondary:   Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau   [ Time Frame: Day 14 post-dose ]
  Show Outcome Measure 7

8.  Secondary:   Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½   [ Time Frame: Day 14 post-dose ]
  Show Outcome Measure 8


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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: Annie Frimm, Vice President Regulatory Affairs, SIGA Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00907803     History of Changes
Other Study ID Numbers: SIGA-246-004, DMID 08-0055
Study First Received: May 21, 2009
Results First Received: July 29, 2010
Last Updated: September 15, 2010
Health Authority: United States: Food and Drug Administration