Phase 2
N=107
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
Orthopoxviral Disease
Bottom Line
View on ClinicalTrials.gov: NCT00907803 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: 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 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ST-246 400 mg (Drug); ST-246 600 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SIGA Technologies
- Primary completion
- Jan 2010
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: Cmax |
1286; 1523 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax |
4; 3 | — |
| 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: AUCtau |
12026; 14791 | — |
| SECONDARY Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½ |
26; 24 | — |
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.
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.