Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SIGA Technologies
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Subject Inclusion Criteria:

• Healthy volunteers

• Ability to Consent

• Not taking any other medication

• Adequate venous access

• Using adequate birth control

Subject Exclusion Criteria:

• Inability to swallow study medication.

• Pregnant or breastfeeding

• Received experimental drug within 30 days of study entry or will participate in any experimental study during the study period.

• Current drug abuse, alcohol abuse, or homelessness.

• Taking concomitant medication

• Lactose Intolerance

• Medical condition; e.g., asthma, diabetes, thyroid disease, angioedema, BMI >35 or <18, hypertension, bleeding disorder, malignancy, seizure, neutropenia, Hepatitis B or C, HIV or AIDS.

• Any condition, occupational reason or other responsibility that, in the judgment of the Investigator, would jeopardize the safety or rights of a volunteer, or render the subject unable to comply with the protocol