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 range18 Years – 50 Years

SexALL

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.

Exclusion criteria

✕. Marked baseline prolongation of QT/corrected QT interval (QTc) interval (
✕. History of additional risk factors for Torsade de Pointes
✕. Clinically significant abnormal ECG
✕. Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or prolongation of the PR interval
✕. Family history of Sudden Cardiac Death not clearly due to acute myocardial infarction.
✕. History of any clinically significant conditions including:
✕. Family history of idiopathic seizures
✕. History or presence of neutropenia or other blood dyscrasia

What they're measuring

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

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

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

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

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

Trial details

NCT IDNCT00728689

SponsorSIGA Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-10

Results submitted2009-06-10

View on ClinicalTrials.gov More Orthopoxviral Disease trials

Who can participate

Age range18 Years – 50 Years

SexALL

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.

Exclusion criteria

✕. Marked baseline prolongation of QT/corrected QT interval (QTc) interval (
✕. History of additional risk factors for Torsade de Pointes
✕. Clinically significant abnormal ECG
✕. Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or prolongation of the PR interval
✕. Family history of Sudden Cardiac Death not clearly due to acute myocardial infarction.
✕. History of any clinically significant conditions including:
✕. Family history of idiopathic seizures
✕. History or presence of neutropenia or other blood dyscrasia