Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-08 @ 5:56 AM
Study NCT ID:
NCT02445794
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A First in Human Study of RT001 in Patients With Friedreich's Ataxia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005621', 'term': 'Friedreich Ataxia'}], 'ancestors': [{'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'C000634027', 'term': 'RT001'}], 'ancestors': [{'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'frederic@retrotope.com', 'phone': '650-437-0700', 'title': 'Frederic Heerinckx/VP Clinical Operations', 'phoneExt': '109', 'organization': 'Retrotope, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 - RT001 (1.8 g/Day)', 'description': 'RT001, oral, 2 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1 - Comparator', 'description': 'RT001 comparator, oral, 2 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2 - RT001 (9 g/Day)', 'description': 'RT001, oral, 10 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Cohort 2 - Comparator', 'description': 'RT001 comparator, oral, 10 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'notes': 'Most of the TEAEs were mild gastrointestinal distress due to the fat content of the study drug (both active and the comparator.) They were self-limited.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'facial fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Steatorrhea requiring overnight hospitalization', 'notes': 'The subject developed severe steatorrhea after a single dose of RT001. This required overnight hospitalization. The condition resolved after within 24 hours after drug discontinuation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - RT001 (1.8 g/Day)', 'description': 'RT001, oral, 2 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG001', 'title': 'Cohort 1 - Comparator', 'description': 'RT001 comparator, oral, 2 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}, {'id': 'OG002', 'title': 'Cohort 2 - RT001 (9 g/Day)', 'description': 'RT001, oral, 10 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG003', 'title': 'Cohort 2 - Comparator', 'description': 'RT001 comparator, oral, 10 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Area Under the Concentration-time Curve After a Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RT001, Oral, 1.8 g/Day', 'description': 'RT001, oral, 1.8 g QD for 28 days or matching comparator\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}, {'id': 'OG001', 'title': 'RT001, Oral, 9 g/Day', 'description': 'RT001, oral, 4.5 g BID for 28 days or matching comparator\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}], 'classes': [{'categories': [{'measurements': [{'value': '524', 'spread': '86', 'groupId': 'OG000'}, {'value': '915', 'spread': '251', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'AUC 0-24 hours post-dose (Hours -1.0 to -0.5 (pre-breakfast, pre-dose), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 2: 24 hours following dosing on Day 1 (± 30 min; pre-breakfast, pre-dose) was measured for the low and high dose cohorts after a single dose of RT001', 'unitOfMeasure': 'ug*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Maximum Observed Plasma Concentration After a Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - RT001 (1.8 g/Day)', 'description': 'RT001, oral, 2 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG001', 'title': 'Cohort 2 - RT001 (9 g/Day)', 'description': 'RT001, oral, 10 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '58.6', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Plasma levels were measured for the following time points: Day 1: Hours -1.0 to -0.5 (pre-breakfast, pre-dose), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 2: 24 hours following dosing on Day 1 (± 30 min; pre-breakfast, pre-dose) PK curves were constructed from these data and CMax measured on the curves for the low and high dose cohorts', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Time to Reach Maximum Plasma Concentration After a Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - RT001 (1.8 g/Day)', 'description': 'RT001, oral, 2 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG001', 'title': 'Cohort 2 - RT001 (9 g/Day)', 'description': 'RT001, oral, 10 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.05', 'spread': '0', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'TMax measured for the low and high dose cohorts', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Maximum Observed Plasma Concentration After Final Dose on Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - RT001 (1.8 g/Day)', 'description': 'RT001, oral, 2 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG001', 'title': 'Cohort 2 - RT001 (9 g/Day)', 'description': 'RT001, oral, 10 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'spread': '44.6', 'groupId': 'OG000'}, {'value': '359.9', 'spread': '31.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28-Day 31 (3 days)', 'description': 'After 28 days of dosing, the final dose of RT001 was administered, and PK samples were obtained at the following timepoints (all timepoints refer to final dose on Day 28):\n\nDay 28: Hours -1.0 to -0.5 (pre-breakfast, pre-dose on Day 28), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 29: Hours 24 (± 30 min; pre-breakfast) and 32 (± 30 min) hours following final dose on Day 28 Day 30: 48 hours following final dose on Day 28 (± 30 min; pre-breakfast) Day 31: 72 hours following final dose on Day 28 (± 30 min; pre-breakfast) PK curves were constructed, and CMax at 28 days was determined from these curves', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics - Terminal Half-life Estimation After Final Dose on Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - RT001 (1.8 g/Day)', 'description': 'RT001, oral, 2 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG001', 'title': 'Cohort 2 - RT001 (9 g/Day)', 'description': 'RT001, oral, 10 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'spread': '9.77', 'groupId': 'OG000'}, {'value': '30.3', 'spread': '18.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28-Day 31 (3 days)', 'description': 'After 28 days of dosing, the final dose of RT001 was administered, and PK samples were obtained at the following timepoints (all timepoints refer to final dose on Day 28):\n\nDay 28: Hours -1.0 to -0.5 (pre-breakfast, pre-dose on Day 28), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 29: Hours 24 (± 30 min; pre-breakfast) and 32 (± 30 min) hours following final dose on Day 28 Day 30: 48 hours following final dose on Day 28 (± 30 min; pre-breakfast) Day 31: 72 hours following final dose on Day 28 (± 30 min; pre-breakfast) PK curves were constructed, and T1/2 at 28 days was determined from these curves', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at 28 Days in the Timed 25 Foot Walk (T25FW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - RT001 (1.8 g/Day)', 'description': 'RT001, oral, 2 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG001', 'title': 'Cohort 1 - Comparator', 'description': 'RT001 comparator, oral, 2 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}, {'id': 'OG002', 'title': 'Cohort 2 - RT001 (9 g/Day)', 'description': 'RT001, oral, 10 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG003', 'title': 'Cohort 2 - Comparator', 'description': 'RT001 comparator, oral, 10 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}], 'classes': [{'categories': [{'measurements': [{'value': '.503', 'spread': '3.7751', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '1.1653', 'groupId': 'OG001'}, {'value': '-7.475', 'spread': '28.6458', 'groupId': 'OG002'}, {'value': '.608', 'spread': '2.4182', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk.\n\nT25FW was measured at baseline and at 28 days. These data were compared.', 'unitOfMeasure': 'sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at 28 Days in the Friedreich Ataxia Rating Scale (FARS) - Neurological Score (Minimum Score 0, Maximum Score 125, Lower is Better)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - RT001 (1.8 g/Day)', 'description': 'RT001, oral, 2 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG001', 'title': 'Cohort 1 - Comparator', 'description': 'RT001 comparator, oral, 2 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}, {'id': 'OG002', 'title': 'Cohort 2 - RT001 (9 g/Day)', 'description': 'RT001, oral, 10 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG003', 'title': 'Cohort 2 - Comparator', 'description': 'RT001 comparator, oral, 10 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.22', 'spread': '2.796', 'groupId': 'OG000'}, {'value': '-6.47', 'spread': '4.768', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '2.080', 'groupId': 'OG002'}, {'value': '-2', 'spread': '3.464', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': "The FARS-neurological rating scale specifically developed and validated for Friedreich's Ataxia. The FARS-Neurological included evaluations of the neurological signs that specifically reflect neural substrates affected in patients with FA. Based on a neurological examination bulbar (11 points), upper limb coordination (36 points), lower limb coordination (16 points), peripheral nervous system (26 points), and upright stability (36 points) functions were assessed for individual sub-scores (11, 36, 16, 26, and 36) with a maximum score of 125 (Friedreich's Ataxia Study Group, Subramony et al., 2005, Lynch et al., 2006). FARS-Neurologic examinations were conducted by a qualified physician or health professional trained in the use of the FARS format. A lower score is better. The minimum score is 0, the maximum score is 125.", 'unitOfMeasure': 'units on a scale maximum 125', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at 28 Days in Peak Workload for the Treated Population vs. the Comparator Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RT001', 'description': 'RT001, oral (pooled 1.8 g/d + 9.0 g/d)\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'OG001', 'title': 'Cohort 1 - Comparator', 'description': 'RT001 comparator, oral\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}], 'classes': [{'categories': [{'measurements': [{'value': '.08', 'groupId': 'OG000', 'lowerLimit': '-.1', 'upperLimit': '.34'}, {'value': '-.08', 'groupId': 'OG001', 'lowerLimit': '-.3', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '.008', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Peak workload was measured using cardiopulmonary exercise testing at baseline and after 28 days of treatment. The results of treatment were compared to baseline examination.', 'unitOfMeasure': 'watts/kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects unable to start or complete the test were excluded from analysis. Treatment and comparator cohorts were pooled to allow for statistical analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 - RT001 (1.8 g/Day)', 'description': 'RT001, oral, 2 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'FG001', 'title': 'Cohort 1 - Comparator', 'description': 'RT001 comparator, oral, 2 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}, {'id': 'FG002', 'title': 'Cohort 2 - RT001 (9 g/Day)', 'description': 'RT001, oral, 10 capsules/day\n\nRT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.'}, {'id': 'FG003', 'title': 'Cohort 2 - Comparator', 'description': 'RT001 comparator, oral, 10 capsules/day\n\nRT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 - RT001', 'description': 'RT001 - 2 capsules/day (1.8 g/day)'}, {'id': 'BG001', 'title': 'Cohort 1 - Comparator', 'description': 'RT001 comparator - 2 capsules/day'}, {'id': 'BG002', 'title': 'Cohort 2 - RT001', 'description': 'RT001 - 10 capsules/day (9 g/day)'}, {'id': 'BG003', 'title': 'Cohort 2 - Comparator', 'description': 'RT001 comparator - 10 capsules/day'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '7.61', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '2.08', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '7.46', 'groupId': 'BG002'}, {'value': '26.3', 'spread': '4.16', 'groupId': 'BG003'}, {'value': '34.3', 'spread': '9.47', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '22.82', 'spread': '3.857', 'groupId': 'BG000'}, {'value': '26.17', 'spread': '2.798', 'groupId': 'BG001'}, {'value': '21.63', 'spread': '3.096', 'groupId': 'BG002'}, {'value': '24.63', 'spread': '7.931', 'groupId': 'BG003'}, {'value': '23.47', 'spread': '4.128', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-24', 'studyFirstSubmitDate': '2015-05-06', 'resultsFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-24', 'studyFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Adverse Events', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics - Area Under the Concentration-time Curve After a Single Dose', 'timeFrame': '24 hours', 'description': 'AUC 0-24 hours post-dose (Hours -1.0 to -0.5 (pre-breakfast, pre-dose), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 2: 24 hours following dosing on Day 1 (± 30 min; pre-breakfast, pre-dose) was measured for the low and high dose cohorts after a single dose of RT001'}, {'measure': 'Pharmacokinetics - Maximum Observed Plasma Concentration After a Single Dose', 'timeFrame': '24 hours', 'description': 'Plasma levels were measured for the following time points: Day 1: Hours -1.0 to -0.5 (pre-breakfast, pre-dose), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 2: 24 hours following dosing on Day 1 (± 30 min; pre-breakfast, pre-dose) PK curves were constructed from these data and CMax measured on the curves for the low and high dose cohorts'}, {'measure': 'Pharmacokinetics - Time to Reach Maximum Plasma Concentration After a Single Dose', 'timeFrame': '24 hours', 'description': 'TMax measured for the low and high dose cohorts'}, {'measure': 'Pharmacokinetics - Maximum Observed Plasma Concentration After Final Dose on Day 28', 'timeFrame': 'Day 28-Day 31 (3 days)', 'description': 'After 28 days of dosing, the final dose of RT001 was administered, and PK samples were obtained at the following timepoints (all timepoints refer to final dose on Day 28):\n\nDay 28: Hours -1.0 to -0.5 (pre-breakfast, pre-dose on Day 28), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 29: Hours 24 (± 30 min; pre-breakfast) and 32 (± 30 min) hours following final dose on Day 28 Day 30: 48 hours following final dose on Day 28 (± 30 min; pre-breakfast) Day 31: 72 hours following final dose on Day 28 (± 30 min; pre-breakfast) PK curves were constructed, and CMax at 28 days was determined from these curves'}, {'measure': 'Pharmacokinetics - Terminal Half-life Estimation After Final Dose on Day 28', 'timeFrame': 'Day 28-Day 31 (3 days)', 'description': 'After 28 days of dosing, the final dose of RT001 was administered, and PK samples were obtained at the following timepoints (all timepoints refer to final dose on Day 28):\n\nDay 28: Hours -1.0 to -0.5 (pre-breakfast, pre-dose on Day 28), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 29: Hours 24 (± 30 min; pre-breakfast) and 32 (± 30 min) hours following final dose on Day 28 Day 30: 48 hours following final dose on Day 28 (± 30 min; pre-breakfast) Day 31: 72 hours following final dose on Day 28 (± 30 min; pre-breakfast) PK curves were constructed, and T1/2 at 28 days was determined from these curves'}, {'measure': 'Change From Baseline at 28 Days in the Timed 25 Foot Walk (T25FW)', 'timeFrame': '28 days', 'description': 'The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk.\n\nT25FW was measured at baseline and at 28 days. These data were compared.'}, {'measure': 'Change From Baseline at 28 Days in the Friedreich Ataxia Rating Scale (FARS) - Neurological Score (Minimum Score 0, Maximum Score 125, Lower is Better)', 'timeFrame': '28 days', 'description': "The FARS-neurological rating scale specifically developed and validated for Friedreich's Ataxia. The FARS-Neurological included evaluations of the neurological signs that specifically reflect neural substrates affected in patients with FA. Based on a neurological examination bulbar (11 points), upper limb coordination (36 points), lower limb coordination (16 points), peripheral nervous system (26 points), and upright stability (36 points) functions were assessed for individual sub-scores (11, 36, 16, 26, and 36) with a maximum score of 125 (Friedreich's Ataxia Study Group, Subramony et al., 2005, Lynch et al., 2006). FARS-Neurologic examinations were conducted by a qualified physician or health professional trained in the use of the FARS format. A lower score is better. The minimum score is 0, the maximum score is 125."}, {'measure': 'Change From Baseline at 28 Days in Peak Workload for the Treated Population vs. the Comparator Population', 'timeFrame': '28 days', 'description': 'Peak workload was measured using cardiopulmonary exercise testing at baseline and after 28 days of treatment. The results of treatment were compared to baseline examination.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Friedreich's Ataxia"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of RT001 in patients with Friedreich's ataxia.", 'detailedDescription': "Study RT001-002 is a randomized, double-blind, controlled, ascending dose study to evaluate the safety, tolerability, pharmacokinetic, disease state, and exploratory endpoints in patients with Friedreich's ataxia after oral administration. The study includes 2 dose levels of RT001."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female 18 to 50 years of age\n2. Medical history consistent with the symptoms of FRDA at ≤ 25 years of age\n3. Homozygous for GAA repeat expansions in the Frataxin gene in the affected range for FRDA\n4. FARS-Neurological score of 20-90 points\n5. Ambulatory (with or without assistive device) and capable of performing assessments/evaluations\n6. Body Mass Index ≤ 29.9 kg/m2\n7. Agrees to dietary restrictions and agrees to receive calls from a dietary coach\n8. Signed the informed consent form prior to entry into the study\n9. Agrees to spend the required number of overnight clinic days\n10. Able to provide the necessary repeated blood samples\n\nExclusion Criteria:\n\n1. Received treatment with other experimental therapies within the last 30 days prior to the first dose\n2. Known point mutation in the FXN gene\n3. History of malignancies (other than basal cell carcinomas)\n4. Impaired renal function at screening\n5. Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values \\> 2 x upper limit of normal (ULN) at screening\n6. Known hepatitis B surface antigen (HBsAg)-positive, or known or suspected active hepatitis C infection, or is known to be human immunodeficiency virus (HIV) positive\n7. Female who is breastfeeding or has a positive pregnancy test\n8. Male participant or female participant of child bearing potential, who is sexually active and unwilling/unable to use a medically acceptable and effective double barrier birth control method throughout the study\n9. Unwilling or unable to comply with the requirements of the protocol\n10. Clinically significant cardiac abnormalities at screening that, in the opinion of the Investigator, would make the patient unsuitable for enrollment\n11. Diabetes mellitus (Type 1 or 2)\n12. Suicidal ideation as determined by the Columbia-Suicide Severity Rating Scale\n13. History, within the last 2 years, of alcohol abuse, significant mental illness, or physical opioid dependence\n14. Cannot adhere to the dietary guidance required to be followed by the protocol\n15. Cannot take the medication due to impairment in swallowing capsules'}, 'identificationModule': {'nctId': 'NCT02445794', 'briefTitle': "A First in Human Study of RT001 in Patients With Friedreich's Ataxia", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biojiva LLC'}, 'officialTitle': "A Randomized, Double-blind, Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of RT001 in Patients With Friedreich's Ataxia", 'orgStudyIdInfo': {'id': 'RT001-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT001, oral, 1.8 g/day', 'description': 'RT001, oral, 1.8 g QD for 28 days or matching comparator', 'interventionNames': ['Drug: Low dose cohort', 'Drug: High dose cohort']}, {'type': 'EXPERIMENTAL', 'label': 'RT001, oral, 9 g/day', 'description': 'RT001, oral, 4.5 g BID for 28 days or matching comparator', 'interventionNames': ['Drug: Low dose cohort', 'Drug: High dose cohort']}], 'interventions': [{'name': 'Low dose cohort', 'type': 'DRUG', 'otherNames': ['RT001 1.8 g/d (2 capsule per day)', 'RT001 comparator 1.8 g/d (2 capsule per day)'], 'description': 'RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.', 'armGroupLabels': ['RT001, oral, 1.8 g/day', 'RT001, oral, 9 g/day']}, {'name': 'High dose cohort', 'type': 'DRUG', 'otherNames': ['RT001 9.0 g/d (9 capsule per day)', 'RT001 comparator 9.0 g/d (9 capsule per day)'], 'description': 'RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.', 'armGroupLabels': ['RT001, oral, 1.8 g/day', 'RT001, oral, 9 g/day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, LLC', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Curtis Scribner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biojiva LLC'}, {'name': 'Theresa Zesiewicz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USF Ataxia Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biojiva LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}