Phase 2
Completed N=107
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
Orthopoxviral Disease
Source: ClinicalTrials.gov NCT00907803 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: 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. — 34; 38; 15 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
34; 38; 15 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax |
1286; 1523 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax |
4; 3 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau |
12026; 14791 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½ |
26; 24 | — |
Eligibility Criteria
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)
- Clinically abnormal ECG
- Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
- Cannot or will not do physical exercise 24 hrs before and after PK days
- Will not consume grapefruit/grapefruit juice during study
- Vaccination within 2 wks of screening, or planned before Day 42 of study
- Treatment with prednisone or equivalent immunosuppressant/modulatory drug <3 mths before screening
- Clinically significant physical exam and lab results <2weeks from 1st study drug dose
Data sourced from ClinicalTrials.gov (NCT00907803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.