Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers (SIGA-246-002)

SIGA Technologies

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ST-246

Drug: Placebo

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00431951

DMID 06-0080 (Other Identifier)

ST-246 RD PHS 1

Details and patient eligibility

About

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.

Full description

This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally administered ST-246 to 30 healthy volunteers ages 18-50 years, randomized to receive either active drug (8 subjects) or placebo (2 subjects) in 1 of 3 dosing groups (250, 400 or 800mg groups). Each dose group of 10 was divided into two cohorts of 5 subjects (4 active and 1 placebo). The first cohort was dosed approximately 4-8 weeks before the second cohort of each dose group. Dose groups completed the study treatment approximately 5 weeks prior to the start of the following dose group. Study procedures included several overnight stays, medical history/exam, laboratory testing done by blood draw, and electrocardiograms.

Enrollment

30 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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