Orthopoxviral Disease Clinical Trial
— 246-SafetyOfficial title:
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Assess Safety, Tolerability, and PK of the Anti-Orthopoxvirus Compound ST-246 When Administered as a Single Daily Oral Dose for 14 Days in Volunteers in the Fed State
| Verified date | September 2010 |
| Source | SIGA Technologies |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 107 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 duration Exclusion Criteria: 1. Inability to swallow study medication 2. Pregnant or breast-feeding 3. 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, 4. History of drug allergy that contraindicates study participation 5. 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) 6. Clinically abnormal ECG 7. Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study 8. Cannot or will not do physical exercise 24 hrs before and after PK days 9. Will not consume grapefruit/grapefruit juice during study 10. Vaccination within 2 wks of screening, or planned before Day 42 of study 11. Treatment with prednisone or equivalent immunosuppressant/modulatory drug <3 mths before screening 12. Clinically significant physical exam and lab results <2weeks from 1st study drug dose |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| United States | Hawaii Clinical Research Center | Honolulu | Hawaii |
| United States | Orlando Clinical Research Center | Orlando | Florida |
| United States | Apex Research Institute | Santa Ana | California |
| Lead Sponsor | Collaborator |
|---|---|
| SIGA Technologies | National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 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. | Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose | No |
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax | Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data | Day 1 post-dose | No |
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax | Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data | Day 14 post-dose | No |
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax | Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles | Day 1 post-dose | No |
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax | Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles | Day 14 post-dose | No |
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau | AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule | Day 1 post-dose | No |
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau | AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule | Day 14 post-dose | No |
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½ | t½: Observed terminal elimination half-life determined after the last dose on Day 14 | Day 14 post-dose | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00728689 -
Phase I Trial of an Investigational Small Pox Medication
|
Phase 1 |