Status:
COMPLETED
Phase I Trial of an Investigational Small Pox Medication
Lead Sponsor:
SIGA Technologies
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Orthopoxviral Disease
Smallpox
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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.
Detailed Description
This was a Phase I, double-blind, cross-over, single-dose study of the orally administered anti-orthopoxvirus compound, ST-246, to 12 healthy, fed volunteers between the ages of 18 and 50 years. Subje...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Inability to swallow medication
- Body Mass Index above 35 or below 18,
- Current drug abuse or alcohol abuse.
- Inability to refrain from physical exercise for a period of 24 hr before and after a PK day or refrain from consuming xanthines, grapefruit or grapefruit juice
- Clinically significant lactose intolerance
- Received experimental drug within 30 days
- Vaccination within 30 days
- Total of more than 350 milliliters (mL) of blood drawn in 2 months
- Treatment with any immunosuppressant or immunomodulatory medication in 3 months
- Any condition occupational reason or other responsibility that, in the judgment of the PI, would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
- History or diagnosis that would affect absorption of study medication
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00728689
Start Date
August 1 2008
End Date
October 1 2008
Last Update
June 29 2015
Active Locations (1)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809