NCT00431951

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

May 7, 2010

Completed
Last Updated

July 27, 2017

Status Verified

September 1, 2010

Enrollment Period

1 year

First QC Date

February 2, 2007

Results QC Date

May 29, 2009

Last Update Submit

July 25, 2017

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table

    Evaluated safety parameters included: 1. physical examination/vital signs 2. electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett) 3. laboratory safety tests (hematology, chemistry, urinalysis) 4. adverse events (AEs) For a)-c), statistical values (mean, standard deviation, median, minimum, maximum) and changes from baseline (Day 1 pre-dose) to each time-point, were compared to laboratory normal reference ranges. If values for a)-d) were a Grade 3 or higher (in DAIDS AE Table)and ST-246-related, they were considered severe and significant, respectively.

    Days 1, 6, 14-16, 21-24, 28-31, and 51-53

Secondary Outcomes (12)

  • Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax

    Day 1

  • Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax

    Day 6

  • Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax

    Day 21

  • Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax

    Day 1

  • Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax

    Day 6

  • +7 more secondary outcomes

Study Arms (2)

ST-246

EXPERIMENTAL

250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days

Drug: ST-246

placebo

PLACEBO COMPARATOR

Placebo to match ST-246

Drug: Placebo

Interventions

ST-246DRUG

250 mg, 400 mg or 800 mg capsules given once daily for 21 days

Also known as: Tecovirimat
ST-246
PlaceboDRUG

Capsules to match experimental drug

Also known as: Placebo to match ST-246
placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Ability to Consent
  • Not taking any other medication
  • Adequate venous access
  • Using adequate birth control

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Clinical Research

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

tecovirimat

Results Point of Contact

Title
Annie Frimm, Vice President, Regulatory Affairs
Organization
SIGA Technologies, Inc.
afrimm@siga.com
951-303-8797

Study Officials

  • Thomas C Marbury, MD

    Orlando Clinical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 6, 2007

Study Start

February 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

July 27, 2017

Results First Posted

May 7, 2010

Record last verified: 2010-09

Locations

US(1)