Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246 (246-Safety)
This study has been completed.
First Received: May 21, 2009   Last Updated: January 21, 2010   History of Changes
Sponsor: SIGA Technologies
Collaborator: National Institutes of Health (NIH)
Information provided by: SIGA Technologies
ClinicalTrials.gov Identifier: NCT00907803
  Purpose

Enroll ~112 male/female subjects to whom either ST-246 (400 or 600mg) or placebo will be given for 14 days to assess the safety, tolerability and pharmacokinetics of ST-246.


Condition Intervention Phase
Orthopoxviral Disease
Drug: ST-246 400 mg
Drug: ST-246 600 mg
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
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

Resource links provided by NLM:


Further study details as provided by SIGA Technologies:

Primary Outcome Measures:
  • Evaluation of safety parameters to assess the number of study participants who tolerated 400mg or 600 mg of ST-246 administered as a single, daily, oral dose for 14 days [ Time Frame: Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters for 400mg or 600 mg of ST-246 administered as a single, daily, oral dose for 14 days: t½ [ Time Frame: Day 14 post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters for 400mg or 600 mg of ST-246 administered as a single, daily, oral dose for 14 days: Cmax [ Time Frame: Day 1 at baseline and 2, 4, 6, 12, 24 hours post-dose. Days 2, 5, 6, 8, 12, 13 at pre-dose. Day 14 at pre-dose and 2, 4, 6, 12, 24, 48, 72, 96, and 120 hours post-dose. ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters for 400mg or 600 mg of ST-246 administered as a single, daily, oral dose for 14 days: Tmax [ Time Frame: Day 1 at baseline and 2, 4, 6, 12, 24 hours post-dose. Days 2, 5, 6, 8, 12, 13 at pre-dose. Day 14 at pre-dose and 2, 4, 6, 12, 24, 48, 72, 96, and 120 hours post-dose. ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters for 400mg or 600 mg of ST-246 administered as a single, daily, oral dose for 14 days: AUCtau [ Time Frame: Day 1 at baseline and 2, 4, 6, 12, 24 hours post-dose. Days 2, 5, 6, 8, 12, 13 at pre-dose. Day 14 at pre-dose and 2, 4, 6, 12, 24, 48, 72, 96, and 120 hours post-dose. ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ST-246 400 mg: Experimental
ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days
Drug: ST-246 400 mg
Capsules, 400 mg daily for 14 days
ST-246 600 mg: Experimental
ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days
Drug: ST-246 600 mg
Capsules, 600 mg daily for 14 days
Placebo: Placebo Comparator
Matching Placebo capsules, Orally Once Daily for 14 days
Drug: Placebo
Capsules, once daily for 14 days

Detailed Description:

This study is primarily a safety study which will also gather information on the pharmacokinetics of ST-246 to support the choice of final dose to be used in expanded pivotal safety trials.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 - 75 yrs
  2. Available for clinical follow-up for study duration
  3. Able/willing to give written consent
  4. Good general health; no clinically significant medical history
  5. Adequate venous access
  6. PE and lab results without clinically significant findings <14d from 1st study drug dose
  7. Body mass index <35
  8. Able and willing to avoid alcohol for screening and study duration
  9. Negative beta-hCG pregnancy test (urine or serum) at screening and Day 1.
  10. Participant or partner has undergone surgical sterilization, or participant has been post-menopausal for >1 year, is heterosexually inactive (abstinent), or uses contraception (screening - 3 months after last study drug dose): Condoms (male or female), diaphragm/cervical cap, or intrauerine device, all with spermicide, or oral contraceptives or other hormonal methods

Exclusion Criteria:

  1. Pregnant, breast-feeding, or planning to become pregnant <3 mths after last study drug dose
  2. History of clinically significant conditions including:

    • Asthma treated with systemic steroids in last 6 mths
    • Serious angioedema in last 3 yrs, or needing medication in last 2 yrs
    • Hypertension with repeated >140 systolic and/or >90 diastolic
    • Head trauma and diagnosis of traumatic brain injury other than concussion
    • Family history of idiopathic seizures
  3. Activity limitations due to cardiac disease
  4. Diagnosed bleeding disorder, e.g., factor deficiency, coagulopathy, or platelet disorder, or severe bruising/bleeding with IM injections or blood draws
  5. Current use of insulin, anti-convulsive, or anti-coagulation therapy
  6. Active malignancy, or malignancy treatment with no assurance of sustained cure, or recurrence likely during study period
  7. History of seizure
  8. Clinically significant blood dyscrasia
  9. History of drug allergy that contraindicates study participation
  10. 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 homelessness)
  11. Inability to swallow study medication
  12. Clinically abnormal ECG
  13. QTcF (Fridericia's correction) >450 msec
  14. Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
  15. Drug or alcohol abuse within the last year. Drug screening for ethanol, amphetamines/methamphetamines, cannabinoids, opiates, cocaine and barbiturates
  16. Must do physical exercise 24 hrs before and after PK days
  17. Must consume grapefruit/grapefruit juice during study
  18. Vaccination within 2 wks of screening, or planned before Day 42 of study
  19. Total >350mL blood (not plasma) drawn <2 mths before given study drug or after study completion
  20. Current clinical bacterial, fungal, mycobacterial or viral infection
  21. Known Hepatitis B or C infection or positive test at screening (determination of HBsAg, HBcAb, and HCVAb)
  22. Known HIV infection or AIDS, or positive test regardless of CD4 count for HIV at screening
  23. Chronic viral infection, e.g., human T-cell lymphotropic Virus I or II
  24. Chronic bacterial, mycobacterial, fungal, parasitic or protozoal infection, except clinically insignificant dermal infections
  25. Treatment with >20 mg prednisone or equivalent immunosuppressant/modulatory drug dose <3 mths before screening
  26. Lab results <14 days prior to first study drug dose, as follows:

    • Serum creatinine clearance (Cockcroft-Gault) <30 mL/min
    • Creatinine in males >1.7 and females >1.4 (1.3X upper limit of normal central lab range (ULN))
    • Hemoglobin < or = 10% below ULN, or higher
    • WBC not within CL normal range
    • Absolute neutrophil count <1,000/mm3
    • Platelets not within 10% of normal CL range
    • Alanine aminotransferase >2X ULN
    • Aspartate aminotransferase >2X ULN
    • Alkaline phosphatase >10% above ULN
    • Hemoglobin A1c > or = 7.0 (includes diabetics on controlled diets or oral hypoglycemics)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907803

Locations
United States, California
Apex Research Institute
Santa Ana, California, United States, 92705
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Hawaii
Hawaii Clinical Research Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
SIGA Technologies
Investigators
Principal Investigator: Dennis E Hruby, PhD SIGA Technologies
  More Information

No publications provided

Responsible Party: SIGA Technologies, Inc. ( Annie Frimm, Vice President Regulatory Affairs )
Study ID Numbers: SIGA-246-004, DMID 08-0055
Study First Received: May 21, 2009
Last Updated: January 21, 2010
ClinicalTrials.gov Identifier: NCT00907803     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by SIGA Technologies:
Orthopoxvirus
Smallpox
This is a safety study only
ST-246 is being studied for treatment of Orthopoxviruses

ClinicalTrials.gov processed this record on February 08, 2010