Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SIGA Technologies
• Collaborator: National Institutes of Health (NIH)

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