Escalating Multiple-Dose Phase 1 Safety, Tolerability & PK Trial 21 Days in Healthy Volunteers - Full Text View

Sponsors and Collaborators:	SIGA Technologies National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	SIGA Technologies
ClinicalTrials.gov Identifier:	NCT00431951

Purpose

The purpose of this study is to see how safe taking 1 dose per day of ST-246 for 21 days is. Thirty healthy volunteers, ages 18-50, will be involved in the study for approximately 8 weeks. Study procedures will include several overnight stays, medical history/exam, laboratory testing done by blood draw, and electrocardiogram which gives a picture of how the heart is working.

Condition	Intervention	Phase
Healthy	Drug: ST-246	Phase I

Drug Information available for: ST-246

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study
Official Title:	Double-Blind,Randomized,Placebo-Controlled, Escalating Multiple-Dose,Phase I Trial to Assess the Safety, Tolerability and Pharmacokinetics of SIGA-246 as a Single Daily Dose for 21 Days in Healthy, Non-Fasted Volunteers

Further study details as provided by SIGA Technologies:

Primary Outcome Measures:

Assess the safety and tolerability of a single dose per day of
ST-246 for 21 days of exposure in humans through history,
physical examination, EKG, and laboratory tests

Secondary Outcome Measures:

Assess the pharmacokinetics of SIGA-246 in healthy volunteers
for the range of doses administered.

Estimated Enrollment:	30
Study Start Date:	February 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This is a double-blind,placebo-controlled,dose-escalating multiple-dose study of oral 250, 400 or 800mg ST-246 in healthy volunteers randomized to active drug in 1 of 3 dosing groups (8 per dose group), while the 6 remaining volunteers (2 per dose group) will receive placebo. The first 5 subjects of each group will be dosed approximately 1 week before the second 5 subjects of each group. The primary outcome is to study the safety, tolerability and PK of a single dose per day of SIGA-246 for 21 days of exposure in humans through history, physical exam, and EKG and laboratory tests.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431951

Locations

United States, Florida
Orlando Clinical Research
Orlando, Florida, United States, 32809

Sponsors and Collaborators

SIGA Technologies

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Thomas C Marbury, MD

Orlando Clinical Research

More Information

No publications provided

Study ID Numbers:	ST-246 RD PHS 1, SIGA-246-002
Study First Received:	February 2, 2007
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00431951 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by SIGA Technologies:

Healthy Volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009