Phase I Trial of an Investigational Small Pox Medication (NCT00728689) | Clinical Trial Compass
CompletedPhase 1
Phase I Trial of an Investigational Small Pox Medication
United States12 participantsStarted 2008-08
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 to 50 years
. Available for clinical follow-up duration of study.
. Able/willing to give written consent.
. Good general health; no clinically significant medical history.
. Refrain from taking any medications from screening through 72 hours after last dose.
. Adequate venous access.
. PE and lab results without clinically significant findings within 28 days prior to receipt of drug.
. Meet Lab Criteria within 28 days prior to receipt of drug.
. History of additional risk factors for Torsade de Pointes
. Clinically significant abnormal ECG
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: t½
Timeframe: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs
2
Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-τ
Timeframe: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs
3
Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-∞
Timeframe: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs
4
Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Cmax
Timeframe: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs
5
Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Tmax
Timeframe: Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs