Clinical trial NCT00907803: Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Orthopoxviral Disease
Keywords: Orthopoxvirus
Smallpox
This is a safety study only
ST-246 is being studied for treatment of Orthopoxviruses
Lead sponsor: SIGA Technologies
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-05-25
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed description: This study is a Phase II, double-blind, randomized, placebo-controlled, multi-center (3 sites) trial to assess the safety, tolerability, and pharmacokinetics of 400 mg and 600 mg Form I ST-246 when administered as a single daily oral dose for 14 days to 107 healthy, fed volunteers between 18 and 74 years of age. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
timeFrame: Day 1 post-dose
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
timeFrame: Day 14 post-dose
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
timeFrame: Day 1 post-dose
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
timeFrame: Day 14 post-dose
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
timeFrame: Day 1 post-dose
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
timeFrame: Day 14 post-dose
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½
timeFrame: Day 14 post-dose
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Honolulu
country: United States
facility: Hawaii Clinical Research Center
state: Hawaii
Study officials:
affiliation: Orlando Clinical Research Center
name: Thomas Marbury, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Apex Research Institute
name: Erik Ross, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hawaii Clinical Research Center
name: Jon Ruckle, MD
role: PRINCIPAL_INVESTIGATOR
References: