Phase I Trial of an Investigational Small Pox Medication

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

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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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
Overall Participants Analyzed  [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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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
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