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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00907803 | Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246 | PHASE2 | COMPLETED | 107 | — | — | Jun 1, 2009 | Jan 1, 2010 | Sep 21, 2010 | 3 | United States |
Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.
| Arm | Type | Description |
|---|---|---|
| ST-246 400 mg | EXPERIMENTAL | ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days |
| ST-246 600 mg | EXPERIMENTAL | ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo capsules, Orally Once Daily for 14 days |
| Name | Type | Description |
|---|---|---|
| ST-246 400 mg | DRUG | Capsules, 400 mg daily for 14 days |
| ST-246 600 mg | DRUG | Capsules, 600 mg daily for 14 days |
| Placebo | DRUG | Capsules, once daily for 14 days |
Inclusion Criteria: 1. 18 - 75 yrs 2. Healthy volunteer 3. Ability to consent 4. Available for clinical follow-up for study 5. Not taking other medications 6. Adequate venous access 7. Using adequate birth control; negative pregnancy test 8. Able and willing to avoid alcohol for screening and study...