Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-31 @ 9:52 AM
Study NCT ID:
NCT00907803
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2009-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012899', 'term': 'Smallpox'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505045', 'term': 'tecovirimat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'afrimm@siga.com', 'phone': '951-303-8797', 'title': 'Annie Frimm, Vice President, Regulatory Affairs', 'organization': 'SIGA Technologies, Inc.'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'Study drug was administered once a day to each dosing group for 14 days, and subjects were followed for an additional 28 days. AEs were recorded throughout this time period.', 'eventGroups': [{'id': 'EG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.', 'otherNumAtRisk': 45, 'otherNumAffected': 11, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.', 'otherNumAtRisk': 46, 'otherNumAffected': 8, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Axillary pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'OG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As per protocol. During the study, a total of 6 withdrawals occurred. These were due to adverse events (2) and consent withdrawal (1) in the 400 mg group, and subject request (1), lost to follow-up (1) and protocol violation (1) in the 600 mg group.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'OG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1170', 'spread': '429', 'groupId': 'OG000'}, {'value': '1467', 'spread': '626', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 post-dose', 'description': 'Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'OG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1286', 'spread': '449', 'groupId': 'OG000'}, {'value': '1523', 'spread': '607', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 post-dose', 'description': 'Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'OG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '1', 'groupId': 'OG000'}, {'value': '4', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 post-dose', 'description': 'Tmax: Time to reach maximum drug concentration in plasma calculated from \\[plasma\\] versus time profiles', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'OG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '1', 'groupId': 'OG000'}, {'value': '3', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 post-dose', 'description': 'Tmax: Time to reach maximum drug concentration in plasma calculated from \\[plasma\\] versus time profiles', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 and 5 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'OG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '11329', 'spread': '4945', 'groupId': 'OG000'}, {'value': '13895', 'spread': '5702', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 post-dose', 'description': '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', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 23 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ) before the 24-hour dosing interval was complete.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'OG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '12026', 'spread': '4255', 'groupId': 'OG000'}, {'value': '14791', 'spread': '5712', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 post-dose', 'description': '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', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 5 and 6 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).'}, {'type': 'SECONDARY', 'title': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'OG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '11', 'groupId': 'OG000'}, {'value': '24', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 post-dose', 'description': 't½: Observed terminal elimination half-life determined after the last dose on Day 14', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 21 and 20 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'FG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal of consent - long commute', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "This study was conducted at three sites: Apex Research Institute, Santa Ana, CA, Hawaii Clinical Research Center, Honolulu, HI, and Orlando Clinical Research Center, Orlando, FL. The study was conducted in male and female volunteers ages 18 - 75 years inclusive from the sites' databases.", 'preAssignmentDetails': 'Following an up to 14-day Screening Period, eligible subjects were randomly assigned to receive either ST-246 400 mg (n=45) or ST-246 600 mg (n=46) or placebo (n=16). Treatment was orally administered after a light meal over a 14-day Treatment Period. There was a 28-day Follow-up Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ST-246 400 mg', 'description': '400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.'}, {'id': 'BG001', 'title': 'ST-246 600 mg', 'description': '600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '15.22', 'groupId': 'BG000'}, {'value': '43.7', 'spread': '15.81', 'groupId': 'BG001'}, {'value': '42.5', 'spread': '17.03', 'groupId': 'BG002'}, {'value': '42.5', 'spread': '15.64', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-15', 'studyFirstSubmitDate': '2009-05-21', 'resultsFirstSubmitDate': '2010-07-29', 'studyFirstSubmitQcDate': '2009-05-22', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-29', 'studyFirstPostDateStruct': {'date': '2009-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax', 'timeFrame': 'Day 1 post-dose', 'description': 'Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data'}, {'measure': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax', 'timeFrame': 'Day 14 post-dose', 'description': 'Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data'}, {'measure': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax', 'timeFrame': 'Day 1 post-dose', 'description': 'Tmax: Time to reach maximum drug concentration in plasma calculated from \\[plasma\\] versus time profiles'}, {'measure': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax', 'timeFrame': 'Day 14 post-dose', 'description': 'Tmax: Time to reach maximum drug concentration in plasma calculated from \\[plasma\\] versus time profiles'}, {'measure': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau', 'timeFrame': 'Day 1 post-dose', 'description': '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'}, {'measure': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau', 'timeFrame': 'Day 14 post-dose', 'description': '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'}, {'measure': 'Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½', 'timeFrame': 'Day 14 post-dose', 'description': 't½: Observed terminal elimination half-life determined after the last dose on Day 14'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Orthopoxvirus', 'Smallpox', 'This is a safety study only', 'ST-246 is being studied for treatment of Orthopoxviruses'], 'conditions': ['Orthopoxviral Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 - 75 yrs\n2. Healthy volunteer\n3. Ability to consent\n4. Available for clinical follow-up for study\n5. Not taking other medications\n6. Adequate venous access\n7. Using adequate birth control; negative pregnancy test\n8. Able and willing to avoid alcohol for screening and study duration\n\nExclusion Criteria:\n\n1. Inability to swallow study medication\n2. Pregnant or breast-feeding\n3. 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,\n4. History of drug allergy that contraindicates study participation\n5. 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)\n6. Clinically abnormal ECG\n7. Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study\n8. Cannot or will not do physical exercise 24 hrs before and after PK days\n9. Will not consume grapefruit/grapefruit juice during study\n10. Vaccination within 2 wks of screening, or planned before Day 42 of study\n11. Treatment with prednisone or equivalent immunosuppressant/modulatory drug \\<3 mths before screening\n12. Clinically significant physical exam and lab results \\<2weeks from 1st study drug dose'}, 'identificationModule': {'nctId': 'NCT00907803', 'acronym': '246-Safety', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246', 'organization': {'class': 'INDUSTRY', 'fullName': 'SIGA Technologies'}, 'officialTitle': 'Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Assess Safety, Tolerability, and PK of the Anti-Orthopoxvirus Compound ST-246 When Administered as a Single Daily Oral Dose for 14 Days in Volunteers in the Fed State', 'orgStudyIdInfo': {'id': 'SIGA-246-004'}, 'secondaryIdInfos': [{'id': 'DMID 08-0055', 'type': 'OTHER', 'domain': 'NIH Contract: HHSN261002600014C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ST-246 400 mg', 'description': 'ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days', 'interventionNames': ['Drug: ST-246 400 mg']}, {'type': 'EXPERIMENTAL', 'label': 'ST-246 600 mg', 'description': 'ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days', 'interventionNames': ['Drug: ST-246 600 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo capsules, Orally Once Daily for 14 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ST-246 400 mg', 'type': 'DRUG', 'otherNames': ['Tecovirimat'], 'description': 'Capsules, 400 mg daily for 14 days', 'armGroupLabels': ['ST-246 400 mg']}, {'name': 'ST-246 600 mg', 'type': 'DRUG', 'otherNames': ['Tecovirimat'], 'description': 'Capsules, 600 mg daily for 14 days', 'armGroupLabels': ['ST-246 600 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules, once daily for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Apex Research Institute', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Clinical Research Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], 'overallOfficials': [{'name': 'Thomas Marbury, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orlando Clinical Research Center'}, {'name': 'Erik Ross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Apex Research Institute'}, {'name': 'Jon Ruckle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hawaii Clinical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SIGA Technologies', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Annie Frimm, Vice President Regulatory Affairs', 'oldOrganization': 'SIGA Technologies, Inc.'}}}}