Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-04-10 @ 11:55 AM
Study NCT ID:
NCT00614666
Status:
TERMINATED
Last Update Posted:
2025-04-16
First Post:
2008-01-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003047', 'term': 'Coccidioidomycosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011952', 'term': 'nikkomycin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spherule@email.arizona.edu', 'phone': '(520) 626-4968', 'title': 'Dr. John Galgiani', 'organization': 'University of Arizona'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'A - First Dose Level (n=5)', 'description': 'nikkomycin Z 50 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'B - Second Dose Level (n=10)', 'description': 'nikkomycin Z nikkomycin Z 250 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'C - Third Dose Level (n=10)', 'description': 'nikkomycin Z 500 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'D - Fourth Dose Level (n=5)', 'description': 'nikkomycin Z 750 BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo', 'description': 'placebo BID x 14 days\n\nPlacebo: Placebo comparator', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Near syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left lung nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right temple pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentration of Nikkomycin Z in the Blood Over Time (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'A - First Dose Level (n=5)', 'description': 'nikkomycin Z 50 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'OG001', 'title': 'B - Second Dose Level (n=10)', 'description': 'nikkomycin Z nikkomycin Z 250 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'OG002', 'title': 'C - Third Dose Level (n=10)', 'description': 'nikkomycin Z 500 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'OG003', 'title': 'D - Fourth Dose Level (n=5)', 'description': 'nikkomycin Z 750 BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '3.444', 'spread': '0.710', 'groupId': 'OG000'}, {'value': '19.923', 'spread': 'NA', 'comment': 'Standard Deviation not calculable for 1 participant', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '3.900', 'spread': '1.583', 'groupId': 'OG000'}, {'value': '24.045', 'spread': 'NA', 'comment': 'Standard Deviation not calculable for 1 participant', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 0.25, 0.5, 0.75, 1.0, 1.5, 2 , 3, 4, 6, 8 and 12 h hours post-dose on Day 1 and Day 14', 'unitOfMeasure': 'mg*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated after enrollment of 6 subjects'}, {'type': 'PRIMARY', 'title': 'Highest Concentration of Nikkomycin Z in the Blood (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'A - First Dose Level (n=5)', 'description': 'nikkomycin Z 50 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'OG001', 'title': 'B - Second Dose Level (n=10)', 'description': 'nikkomycin Z nikkomycin Z 250 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'OG002', 'title': 'C - Third Dose Level (n=10)', 'description': 'nikkomycin Z 500 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'OG003', 'title': 'D - Fourth Dose Level (n=5)', 'description': 'nikkomycin Z 750 BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.710', 'spread': '0.188', 'groupId': 'OG000'}, {'value': '3.748', 'spread': 'NA', 'comment': 'Standard Deviation not calculable for 1 participant', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.811', 'spread': '0.248', 'groupId': 'OG000'}, {'value': '4.275', 'spread': 'NA', 'comment': 'Standard Deviation not calculable for 1 participant', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 0.25, 0.5, 0.75, 1.0, 1.5, 2 , 3, 4, 6, 8 and 12 h hours post-dose on Day 1 and Day 14', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated after enrollment of 6 subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A - First Dose Level', 'description': 'nikkomycin Z 50 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID vs placebo capsule BID\n* 50 mg BID vs 250 mg BID vs Placebo capsule BID\n* 250 mg BID vs 500 mg BID vs Placebo capsule BID\n* 500 mg BID vs Placebo capsule BID\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'FG001', 'title': 'B - Second Dose Level', 'description': 'nikkomycin Z nikkomycin Z 250 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID vs placebo capsule BID\n* 50 mg BID vs 250 mg BID vs Placebo capsule BID\n* 250 mg BID vs 500 mg BID vs Placebo capsule BID\n* 500 mg BID vs Placebo capsule BID\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'FG002', 'title': 'C - Third Dose Level', 'description': 'nikkomycin Z 500 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID vs placebo capsule BID\n* 50 mg BID vs 250 mg BID vs Placebo capsule BID\n* 250 mg BID vs 500 mg BID vs Placebo capsule BID\n* 500 mg BID vs Placebo capsule BID\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'FG003', 'title': 'D - Fourth Dose Level', 'description': 'nikkomycin Z 750 BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID vs placebo capsule BID\n* 50 mg BID vs 250 mg BID vs Placebo capsule BID\n* 250 mg BID vs 500 mg BID vs Placebo capsule BID\n* 500 mg BID vs Placebo capsule BID\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'placebo BID x 14 days\n\nPlacebo: Placebo comparator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'A - First Dose Level (n=5)', 'description': 'nikkomycin Z 50 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'BG001', 'title': 'B - Second Dose Level (n=10)', 'description': 'nikkomycin Z nikkomycin Z 250 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'BG002', 'title': 'C - Third Dose Level (n=10)', 'description': 'nikkomycin Z 500 mg BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'BG003', 'title': 'D - Fourth Dose Level (n=5)', 'description': 'nikkomycin Z 750 BID x 14 days\n\nnikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'placebo BID x 14 days\n\nPlacebo: Placebo comparator'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Recruitment challenges and lack of funding caused an early end to this study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2008-01-31', 'resultsFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2008-02-12', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-27', 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Nikkomycin Z in the Blood Over Time (AUC)', 'timeFrame': '0, 0.25, 0.5, 0.75, 1.0, 1.5, 2 , 3, 4, 6, 8 and 12 h hours post-dose on Day 1 and Day 14'}, {'measure': 'Highest Concentration of Nikkomycin Z in the Blood (Cmax)', 'timeFrame': '0, 0.25, 0.5, 0.75, 1.0, 1.5, 2 , 3, 4, 6, 8 and 12 h hours post-dose on Day 1 and Day 14'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coccidioidomycosis', 'Valley Fever', 'nikkomycin Z'], 'conditions': ['Coccidioidomycosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.vfce.arizona.edu', 'label': 'The Valley Fever Center for Excellence'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin Z in relation to dose administered. Patients with mild forms of Valley Fever pneumonia will be eligible to participate and will be allocated to receive treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.', 'detailedDescription': 'Every year there are 50,000 new U.S. cases of coccidioidomycosis (Valley Fever). The majority of these illnesses occur as a result of endemic exposure in Arizona and California. The benefits of antifungal therapy for uncomplicated disease are not currently established. Current therapies for serious and complicated forms of coccidioidomycosis are only partially effective and in themselves are unable to eradicate the fungus from sites of infection, commonly resulting in breakthrough infection and/or relapse. Nikkomycin Z is effective in the mouse model and results in improved microbiological response over fluconazole.\n\nThe goals of this study include: 1) Evaluating the safety and tolerance of nikkomycin Z following administration of multiple doses (50 mg Q 12 h to 750 mg Q 8 h) for two week and 2) Evaluating the pharmacokinetics of nikkomycin Z after single and multiple doses in relationship to dose. The study will include patients with uncomplicated Coccidioides pneumonia (mild illness) which will allow exploratory analysis of efficacy and dose response based on biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years and \\<= 50 years\n* Male or Female (if female, must have a negative pregnancy test and agree to use an acceptable contraception method)\n* Able to understand study and give written informed consent\n* Have a respiratory illness with at least one of the following: Cough, chest pain dyspnea or tachypnea, sputum production, or fever/chills/night sweats\n* Have a new or suspected new pulmonary infiltrate on Chest X-ray\n* Have a positive coccidioidal serology by EIA or immunodiffusion\n\nExclusion Criteria:\n\n* Patients under the age of 18 years or over 50 years\n* Patients with a prior history of confirmed coccidioidal infection\n* Laboratory diagnosis of another etiology for the inclusion-defining illness\n* Inability to comprehend study and provide informed consent\n* History of or current evidence of major organ disease\n* Concomitant use of prednisone and other corticosteroids not permitted\n* Concomitant immunosuppressive therapy is not permitted\n* Concomitant antibacterial therapy is not permitted'}, 'identificationModule': {'nctId': 'NCT00614666', 'briefTitle': 'Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Phase I/II Evaluation of the Safety, Pharmacokinetics, and Preliminary Effectiveness of Nikkomycin Z in the Treatment of Patients With Uncomplicated Coccidioides Pneumonia', 'orgStudyIdInfo': {'id': 'VCFE-2007-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A - First dose level (n=5)', 'description': 'nikkomycin Z 50 mg BID x 14 days', 'interventionNames': ['Drug: nikkomycin Z']}, {'type': 'EXPERIMENTAL', 'label': 'B - Second Dose Level (n=10)', 'description': 'nikkomycin Z nikkomycin Z 250 mg BID x 14 days', 'interventionNames': ['Drug: nikkomycin Z']}, {'type': 'EXPERIMENTAL', 'label': 'C - Third Dose Level (n=10)', 'description': 'nikkomycin Z 500 mg BID x 14 days', 'interventionNames': ['Drug: nikkomycin Z']}, {'type': 'EXPERIMENTAL', 'label': 'D - Fourth Dose Level (n=5)', 'description': 'nikkomycin Z 750 BID x 14 days', 'interventionNames': ['Drug: nikkomycin Z']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo BID x 14 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'nikkomycin Z', 'type': 'DRUG', 'description': 'Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.\n\n* 50 mg BID (n=4) vs placebo capsule BID (n=1)\n* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)\n* 500 mg BID (n=4) vs Placebo capsule BID (n=1)\n\nAt least 4 subjects complete lower dose before randomization includes next higher dose.\n\nStage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.', 'armGroupLabels': ['A - First dose level (n=5)', 'B - Second Dose Level (n=10)', 'C - Third Dose Level (n=10)', 'D - Fourth Dose Level (n=5)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85721', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical & Translational Research Center - University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'David E Nix, Pharm D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Study was terminated due to poor enrollment. Study report was not generated beyond safety data.', 'ipdSharing': 'YES', 'description': 'De-identified data may be shared for legitimate use to further nikkomycin Z development.', 'accessCriteria': 'Contact Valley fever Solutions - current license for development.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'FDA Office of Orphan Products Development', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}