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

NCT ID: NCT00907803

Last Updated: 2010-09-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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This study is a Phase II, double-blind, randomized, placebo-controlled, multi-center (3 sites) trial to assess the safety, tolerability, and pharmacokinetics of 400 mg and 600 mg Form I ST-246 when administered as a single daily oral dose for 14 days to 107 healthy, fed volunteers between 18 and 74 years of age. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms.

Conditions

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Orthopoxviral Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ST-246 400 mg

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

Group Type EXPERIMENTAL

ST-246 400 mg

Intervention Type DRUG

Capsules, 400 mg daily for 14 days

ST-246 600 mg

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

Group Type EXPERIMENTAL

ST-246 600 mg

Intervention Type DRUG

Capsules, 600 mg daily for 14 days

Placebo

Matching Placebo capsules, Orally Once Daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules, once daily for 14 days

Interventions

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ST-246 400 mg

Capsules, 400 mg daily for 14 days

Intervention Type DRUG

ST-246 600 mg

Capsules, 600 mg daily for 14 days

Intervention Type DRUG

Placebo

Capsules, once daily for 14 days

Intervention Type DRUG

Other Intervention Names

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Tecovirimat Tecovirimat

Eligibility Criteria

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Inclusion Criteria

1. 18 - 75 yrs
2. Healthy volunteer
3. Ability to consent
4. Available for clinical follow-up for study
5. Not taking other medications
6. Adequate venous access
7. Using adequate birth control; negative pregnancy test
8. Able and willing to avoid alcohol for screening and study duration

Exclusion Criteria

1. Inability to swallow study medication
2. Pregnant or breast-feeding
3. 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,
4. History of drug allergy that contraindicates study participation
5. 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)
6. Clinically abnormal ECG
7. Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
8. Cannot or will not do physical exercise 24 hrs before and after PK days
9. Will not consume grapefruit/grapefruit juice during study
10. Vaccination within 2 wks of screening, or planned before Day 42 of study
11. Treatment with prednisone or equivalent immunosuppressant/modulatory drug \<3 mths before screening
12. Clinically significant physical exam and lab results \<2weeks from 1st study drug dose
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

SIGA Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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SIGA Technologies, Inc.

Principal Investigators

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Thomas Marbury, MD

Role: PRINCIPAL_INVESTIGATOR

Orlando Clinical Research Center

Erik Ross, MD

Role: PRINCIPAL_INVESTIGATOR

Apex Research Institute

Jon Ruckle, MD

Role: PRINCIPAL_INVESTIGATOR

Hawaii Clinical Research Center

Locations

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Apex Research Institute

Santa Ana, California, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Hawaii Clinical Research Center

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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DMID 08-0055

Identifier Type: OTHER

Identifier Source: secondary_id

SIGA-246-004

Identifier Type: -

Identifier Source: org_study_id