Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00728689 | Phase I Trial of an Investigational Small Pox Medication | PHASE1 | COMPLETED | 12 | — | — | Aug 1, 2008 | Oct 1, 2008 | Jun 29, 2015 | 1 | United States |
Mean terminal half-life (t½; hrs) for Forms I and V were calculated from \[plasma\] vs time profiles.
Area under the drug concentration-time curve from time zero to time t, where t is the last timepoint with a drug concentration ≥ lowest obtainable quantification (AUC0-τ; ng\*hr/mL).
Area under the drug concentration-time curve from time zero to infinity (AUC0-∞; ng\*hr/mL).
Maximum drug concentration in plasma, determined directly from individual concentration-time data (Cmax)
Time to maximum plasma concentration(Tmax; hrs) for Forms I and V were calculated from \[plasma\] vs time profiles.
| Arm | Type | Description |
|---|---|---|
| Group ST-246 Form I (followed by Form V) | ACTIVE_COMPARATOR | Each of six subjects receive a single oral 400 mg dose (2×200 mg) of ST-246 Form I (monohydrate) in the first intervention period, followed 10 days later (3 days post-treatment monitoring and 7 days wash-out period) in the second intervention period by a single oral 400 mg dose (2×200 mg) of ST-246 Form V (hemihydrate). Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat. |
| Group ST-246 Form V (followed by Form I) | ACTIVE_COMPARATOR | Each of six subjects receive a single oral 400 mg dose (2×200 mg) of ST-246 Form V (hemihydrate) in the first intervention period, followed 10 days later (3 days post-treatment monitoring and 7 days wash-out period) in the second intervention period by a single oral 400 mg dose (2×200 mg) of ST-246 Form I (monohydrate). Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat. |
| Name | Type | Description |
|---|---|---|
| ST-246 Days 1 - 3 | DRUG | First Intervention is on Days 1 - 3, and includes 6 patients dosed once orally with ST-246 Form I (Arm 1), and 6 patients dosed once orally with ST-246 Form V (Arm 2). |
| ST-246 Days 11 - 13 | DRUG | Second Intervention is on Days 11 - 13 (after a 3 day post-treatment monitoring and 7 day wash-out period) where the 6 patients previously given ST-246 Form I (Arm 1) are now dosed once orally with ST-246 Form V, and the 6 patients previously given ST-246 Form V (Arm 2) are now dosed once orally with ST-246 Form I. |
Inclusion Criteria: 1. 18 to 50 years 2. Available for clinical follow-up duration of study. 3. Able/willing to give written consent. 4. Good general health; no clinically significant medical history. 5. Refrain from taking any medications from screening through 72 hours after last dose. 6. Adequat...