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| ID | Type | Description | Link |
|---|---|---|---|
| DMID 06-0080 | Other Identifier | NIH Contract #: HHSN266200600014C |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ST-246 | Experimental | 250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days |
|
| placebo | Placebo Comparator | Placebo to match ST-246 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST-246 | Drug | 250 mg, 400 mg or 800 mg capsules given once daily for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Days 1, 6, 14-16, 21-24, 28-31, and 51-53 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax | Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data | Day 1 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax |
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Subject Inclusion Criteria:
Subject Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas C Marbury, MD | Orlando Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research | Orlando | Florida | 32809 | United States |
After a 28-day screening and 1-day enrollment period, study drug was administered on Day 1. Ten participants (8 drug:2 placebo) were randomized in each of three dosing groups (250, 400, and 800 mg ST-246). Each group was divided into 2 cohorts of 5 subjects (4 drug:1 placebo), with one cohort receiving drug 4-8 weeks before the other cohort.
This study was conducted at one site, Orlando Clinical Research Center, Orlando, FL. The study was conducted in healthy volunteers from the site's database.
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| ID | Title | Description |
|---|---|---|
| FG000 | ST-246 250 mg | 250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. |
| FG001 | ST-246 400mg | 400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21. |
| FG002 | ST-246 800 mg | 800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21. |
| FG003 | Placebo | Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ST-246 250 mg | 250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. |
| BG001 | ST-246 400mg | 400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each, and one placebo group with 6 subjects. A total of 7 withdrawals during the entire study were due to inability to follow procedure (4), lost to follow-up (1), requested due to concomitant medication (1), and an adverse event (1) | Posted | Number | Participants | Days 1, 6, 14-16, 21-24, 28-31, and 51-53 |
7 weeks
Study drug was administered to each dosing group cohort for 21 days and subjects were followed for an additional 30 to 32 days. AEs were recorded throughout this time period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ST-246 250 mg | 250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Eye Sensation | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annie Frimm, Vice President, Regulatory Affairs | SIGA Technologies, Inc. | 951-303-8797 | afrimm@siga.com |
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| ID | Term |
|---|---|
| C505045 | tecovirimat |
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| Placebo | Drug | Capsules to match experimental drug |
|
|
Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data |
| Day 6 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax | Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data | Day 21 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax | Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles. | Day 1 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax | Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles. | Day 6 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax | Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles. | Day 21 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½ | t½: Observed terminal elimination half-life determined after the last dose on Day 21 | Day 21 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau | AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule | Day 1 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau | AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule | Day 6 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau | AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule | Day 21 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24) | Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21 | Day 1 |
| Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24) | Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21 | Day 21 |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| BG002 | ST-246 800 mg | 800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21. |
| BG003 | Placebo | Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | ST-246 250 mg | 250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. |
| OG001 | ST-246 400mg | 400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. |
| OG002 | ST-246 800 mg | 800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. |
| OG003 | Placebo | Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). |
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax | Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data | Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects | Posted | Mean | Standard Deviation | ng/mL | Day 1 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax | Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data | Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group) | Posted | Mean | Standard Deviation | ng/mL | Day 6 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax | Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data | Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group) | Posted | Mean | Standard Deviation | ng/mL | Day 21 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax | Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles. | Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects | Posted | Mean | Standard Deviation | hours | Day 1 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax | Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles. | Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group) | Posted | Mean | Standard Deviation | hours | Day 6 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax | Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles. | Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group) | Posted | Mean | Standard Deviation | hours | Day 21 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½ | t½: Observed terminal elimination half-life determined after the last dose on Day 21 | Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group). | Posted | Mean | Standard Deviation | hours | Day 21 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau | AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule | Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects | Posted | Mean | Standard Deviation | ng*hr/mL | Day 1 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau | AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule | Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group) | Posted | Mean | Standard Deviation | ng*hr/mL | Day 6 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau | AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule | Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group). | Posted | Mean | Standard Deviation | ng*hr/mL | Day 21 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24) | Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21 | Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects | Posted | Mean | Standard Deviation | mg | Day 1 |
|
|
|
| Secondary | Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24) | Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21 | Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group). | Posted | Mean | Standard Deviation | mg | Day 21 |
|
|
|
| 0 |
| 8 |
| 6 |
| 8 |
| EG001 | ST-246 400mg | 400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21. | 0 | 8 | 2 | 8 |
| EG002 | ST-246 800 mg | 800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21. | 0 | 8 | 5 | 8 |
| EG003 | Placebo | Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21. | 0 | 6 | 4 | 6 |
| Backpain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment | Only one subject, in the 800mg group, experienced a severe headache (TEAE of Grade 3; deemed study-drug related) on Day 15, and discontinued the study. |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
The PI must obtain the sponsor's written consent to publish any study results and must notify the sponsor within 30 working days prior to publishing.