Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246 (NCT00907803) | Clinical Trial Compass
CompletedPhase 2
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
United States107 participantsStarted 2009-06
Plain-language summary
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 18 - 75 yrs
✓. Healthy volunteer
✓. Ability to consent
✓. Available for clinical follow-up for study
✓. Not taking other medications
✓. Adequate venous access
✓. Using adequate birth control; negative pregnancy test
✓. Able and willing to avoid alcohol for screening and study duration
Exclusion criteria
✕. Inability to swallow study medication
✕. Pregnant or breast-feeding
✕. Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
✕. History of drug allergy that contraindicates study participation
✕. Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
What they're measuring
1
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.
Timeframe: Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose