Phase I Trial of an Investigational Small Pox Medication
Condition: Orthopoxviral Disease; Smallpox; Monkey Pox
MeSH terms: Smallpox; Monkeypox
Intervention: ST-246 Days 1 - 3; ST-246 Days 11 - 13
Intervention description: First Intervention is on Days 1 - 3, and includes 6 patients dosed once orally with ST-246 Form I (Arm 1), and 6 patients dosed once orally with ST-246 Form V (Arm 2).; Second Intervention is on Days 11 - 13 (after a 3 day post-treatment monitoring and 7 day wash-out period) where the 6 patients previously given ST-246 Form I (Arm 1) are now dosed once orally with ST-246 Form V, and the 6 patients previously given ST-246 Form V (Arm 2) are now dosed once orally with ST-246 Form I.
Intervention MeSH terms: Tecovirimat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Orthopoxviral; Smallpox; Monkey pox

Summary:

      The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a
      single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 50 years

          2. Available for clinical follow-up duration of study.

          3. Able/willing to give written consent.

          4. Good general health; no clinically significant medical history.

          5. Refrain from taking any medications from screening through 72 hours after last dose.

          6. Adequate venous access.

          7. PE and lab results without clinically significant findings within 28 days prior to
             receipt of drug.

          8. Meet Lab Criteria within 28 days prior to receipt of drug.

          9. Negative pregnancy test

         10. Non smokers

         11. No alcohol or caffeine

         12. Participant or partner has undergone surgical sterilization, or the participant agrees
             either to be abstinent or use two non-hormonal methods of contraception for duration
             of the study

        Exclusion Criteria:

          1. Marked baseline prolongation of QT/corrected QT interval (QTc) interval (

          2. History of additional risk factors for Torsade de Pointes

          3. Clinically significant abnormal ECG

          4. Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal
             episodes, or prolongation of the PR interval

          5. Family history of Sudden Cardiac Death not clearly due to acute myocardial infarction.

          6. History of any clinically significant conditions including:

               -  Asthma

               -  Diabetes mellitus

               -  History of thyroidectomy or thyroid disease

               -  Serious angioedema episodes

               -  Head trauma resulting in a diagnosis of TBI other than concussion

               -  Seizure or history of seizure

               -  Bleeding disorder diagnosed by a doctor or significant bruising or bleeding
                  difficulties with intramuscular injections or blood draws

               -  Malignancy

          7. Family history of idiopathic seizures

          8. History or presence of neutropenia or other blood dyscrasia

          9. Known Hepatitis B or Hepatitis C infection

         10. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
             illness.

         11. Current or recent history of a clinically significant bacterial, fungal, or
             mycobacterial infection.

         12. Known clinically significant chronic viral infection (or current clinically
             significant viral infection

         13. History of frequent or severe headaches or migraines

         14. Known chronic bacterial, mycobacterial, fungal, parasitic, or protozoal infection

         15. Woman who is pregnant or is breast-feeding or planning to become pregnant

         16. On any concomitant medications

         17. History of drug allergy that, in the opinion of the PI, contraindicates participation
             in the trial.

         18. Inability to swallow medication

         19. Body Mass Index above 35 or below 18,

         20. Current drug abuse or alcohol abuse.

         21. Inability to refrain from physical exercise for a period of 24 hr before and after a
             PK day or refrain from consuming xanthines, grapefruit or grapefruit juice

         22. Clinically significant lactose intolerance

         23. Received experimental drug within 30 days

         24. Vaccination within 30 days

         25. Total of more than 350 milliliters (mL) of blood drawn in 2 months

         26. Treatment with any immunosuppressant or immunomodulatory medication in 3 months

         27. Any condition occupational reason or other responsibility that, in the judgment of the
             PI, would jeopardize the safety or rights of a subject participating in the trial or
             would render the subject unable to comply with the protocol

         28. History or diagnosis that would affect absorption of study medication