Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246

NCT00907803 | Completed Phase 2 Results DMC

• 2 other identifiers: SIGA-246-004DMID 08-0055
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.

Conditions

Orthopoxviral Disease

Keywords

Orthopoxvirus; Smallpox; This is a safety study only; ST-246 is being studied for treatment of Orthopoxviruses

Outcome Measures

Primary Outcomes (1)

• Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.

  Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.

  Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose

Secondary Outcomes (7)

• Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax

  Day 1 post-dose

• Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax

  Day 14 post-dose

• Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax

  Day 1 post-dose

• Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax

  Day 14 post-dose

• Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau

  Day 1 post-dose

Study Arms (3)

ST-246 400 mg

EXPERIMENTAL

ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days

Drug: ST-246 400 mg

ST-246 600 mg

EXPERIMENTAL

ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days

Drug: ST-246 600 mg

Placebo

PLACEBO COMPARATOR

Matching Placebo capsules, Orally Once Daily for 14 days

Drug: Placebo

Interventions

ST-246 400 mg DRUG

Capsules, 400 mg daily for 14 days

Also known as: Tecovirimat

ST-246 400 mg

ST-246 600 mg DRUG

Capsules, 600 mg daily for 14 days

Also known as: Tecovirimat

ST-246 600 mg

Placebo DRUG

Capsules, once daily for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs
• Healthy volunteer
• Ability to consent
• Available for clinical follow-up for study
• Not taking other medications
• Adequate venous access
• Using adequate birth control; negative pregnancy test
• Able and willing to avoid alcohol for screening and study duration

You may not qualify if:

• Inability to swallow study medication
• Pregnant or breast-feeding
• Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
• History of drug allergy that contraindicates study participation
• Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
• Clinically abnormal ECG
• Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
• Cannot or will not do physical exercise 24 hrs before and after PK days
• Will not consume grapefruit/grapefruit juice during study
• Vaccination within 2 wks of screening, or planned before Day 42 of study
• Treatment with prednisone or equivalent immunosuppressant/modulatory drug \<3 mths before screening
• Clinically significant physical exam and lab results \<2weeks from 1st study drug dose

Sponsors & Collaborators

• SIGA Technologies: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Hawaii Clinical Research Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Smallpox

Interventions

tecovirimat

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Annie Frimm, Vice President, Regulatory Affairs
• Organization: SIGA Technologies, Inc.

afrimm@siga.com

951-303-8797

Study Officials

• Thomas Marbury, MD

  Orlando Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Erik Ross, MD

  Apex Research Institute

  PRINCIPAL INVESTIGATOR

• Jon Ruckle, MD

  Hawaii Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 21, 2010
• Results First Posted: August 27, 2010

Record last verified: 2010-09

Locations

US (3)