Phase I Trial of an Investigational Small Pox Medication

Completed · Phase 1

Conditions studied: Orthopoxviral Disease, Smallpox, Monkey Pox

In brief

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.

Key facts

Study ID

NCT00728689

Run by

SIGA Technologies

People needed

12

Starts

2008-08-01

Expected to finish

2008-10-01

Last updated by the study team

2015-06-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Negative pregnancy test
• Non smokers
• No alcohol or caffeine
• 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

You may not qualify if…

• 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:
• 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
• Family history of idiopathic seizures
• History or presence of neutropenia or other blood dyscrasia
• Known Hepatitis B or Hepatitis C infection
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome illness.
• Current or recent history of a clinically significant bacterial, fungal, or mycobacterial infection.
• Known clinically significant chronic viral infection (or current clinically significant viral infection
• History of frequent or severe headaches or migraines
• Known chronic bacterial, mycobacterial, fungal, parasitic, or protozoal infection
• Woman who is pregnant or is breast-feeding or planning to become pregnant
• On any concomitant medications
• History of drug allergy that, in the opinion of the PI, contraindicates participation in the trial.

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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