Antiviral tecovirimat put to the test for smallpox threat
NCT ID NCT00907803
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers tested two doses of tecovirimat, an antiviral drug, in healthy volunteers to see how safe and well-tolerated it is. Participants took a daily oral dose for 14 days, and researchers monitored side effects and measured drug levels in the blood. The goal was to find the best dose to carry forward into larger safety trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tecovirimat (ST-246), an antiviral drug
- What this could lead to
- If tecovirimat proves safe and well-tolerated, it could become a stockpiled treatment for smallpox and related orthopoxvirus infections.
- What could go wrong
- This is an early-stage trial in healthy volunteers, so it cannot show whether the drug actually works against orthopoxviruses. Side effects or dosing problems could limit further testing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
107 people
The number who actually took part.
- Start date
-
Jun 2009
- Finished
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Jan 2010
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Apex Research Institute
Santa Ana, California, 92705, United States
-
Hawaii Clinical Research Center
Honolulu, Hawaii, 96813, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States