Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-17 @ 5:03 PM
Study NCT ID:
NCT02998450
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of IMR-687 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D006450', 'term': 'Hemoglobin SC Disease'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C109691', 'term': 'microcrystalline cellulose'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2017-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2016-12-15', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment emergent adverse events and serious adverse events', 'timeFrame': '5 Days'}, {'measure': 'Number of participants with clinically significant changes from baseline in vital signs', 'timeFrame': 'Baseline to Day 5', 'description': 'Vital signs include blood pressure, heart rate, pulse rate, and oral temperature'}, {'measure': 'Number of participants with clinically significant changes from baseline in physical examination', 'timeFrame': 'Baseline to Day 5'}, {'measure': 'Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values', 'timeFrame': 'Baseline to Day 5'}, {'measure': 'Number of participants with clinically significant changes from baseline in 12-lead ECG parameters', 'timeFrame': 'Baseline to Day 2'}, {'measure': 'Use of concomitant medications and therapies, medication type and frequency', 'timeFrame': '5 Days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of IMR-687', 'timeFrame': 'Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose', 'description': 'Maximum Observed Plasma Concentration (Cmax) of IMR-687'}, {'measure': 'Pharmacokinetics (PK) of IMR-687', 'timeFrame': 'Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose', 'description': 'Area under the curve (AUC) ( 0 to 24 h) of IMR-687'}, {'measure': 'Pharmacokinetics (PK) of IMR-687', 'timeFrame': 'Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose', 'description': 'AUC from time 0 to the last measurable time point (AUClast) of IMR-687'}, {'measure': 'Pharmacokinetics (PK) of IMR-687', 'timeFrame': 'Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose', 'description': 'AUC extrapolated to infinity (AUC0 ∞) of IMR-687'}, {'measure': 'Pharmacokinetics (PK) of IMR-687', 'timeFrame': 'Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose', 'description': 'Time to maximum concentration (tmax) of IMR-687'}, {'measure': 'Pharmacokinetics (PK) of IMR-687', 'timeFrame': 'Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose', 'description': 'Apparent terminal half-life (t½) of IMR-687'}, {'measure': 'The change from baseline in QTcF interval.', 'timeFrame': '2 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sickle Cell Disease', 'Sickle Beta 0 Thalassemia'], 'conditions': ['Sickle Cell Disease', 'Sickle-Cell; Hb-SC', 'Sickle Beta 0 Thalassemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, PK and PD profile of the orally administered IMR-687 in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be healthy as judged by the Investigator on the basis of pre-study tests performed at Screening, with healthy body mass index (BMI), healthy body weight, and laboratory results within normal laboratory reference range or determined not to be clinically significant by the Investigator; and be free from drugs of abuse.\n\nExclusion Criteria:\n\n* Females who are pregnant, trying to become pregnant, or breastfeeding; and males with female partners who are trying to conceive.\n* Asthmatics or other individuals who use or may use albuterol rescue inhalers or nebulizers.\n* A significant history of cardiovascular disease.\n* On ECG, a QTcF \\>450 ms or the presence of clinically significant abnormalities as determined by the Investigator.\n* Elevated blood pressure.\n* Use within 30 days prior to Day 1 of any inhibitors or substrates of targets of IMR-687.'}, 'identificationModule': {'nctId': 'NCT02998450', 'briefTitle': 'A Study of IMR-687 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardurion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1a Study of IMR-687 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'IMR-SCD-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '4 Subjects will receive a single low dose of IMR-687, administered orally following an overnight fast.\n\n2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.', 'interventionNames': ['Drug: IMR-687', 'Drug: Placebo Oral Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '4 Subjects will receive a single low-mid dose of IMR-687, administered orally following an overnight fast.\n\n2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.', 'interventionNames': ['Drug: IMR-687', 'Drug: Placebo Oral Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': '4 Subjects will receive a single mid-low dose of IMR-687, administered orally following an overnight fast.\n\n2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.', 'interventionNames': ['Drug: IMR-687', 'Drug: Placebo Oral Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': '4 Subjects will receive a single mid dose of IMR-687, administered orally following an overnight fast.\n\n2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.', 'interventionNames': ['Drug: IMR-687', 'Drug: Placebo Oral Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': '4 Subjects will receive a single mid-high dose of IMR-687, administered orally following an overnight fast.\n\n2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.', 'interventionNames': ['Drug: IMR-687', 'Drug: Placebo Oral Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6', 'description': '4 Subjects will receive a single high dose of IMR-687, administered orally following an overnight fast.\n\n2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.', 'interventionNames': ['Drug: IMR-687', 'Drug: Placebo Oral Capsule']}], 'interventions': [{'name': 'IMR-687', 'type': 'DRUG', 'description': '1 of 6 possible single doses administered orally following overnight fast', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Cohort 6']}, {'name': 'Placebo Oral Capsule', 'type': 'DRUG', 'otherNames': ['Microcrystalline cellulose'], 'description': 'Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Cohort 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Quintiles', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Regulatory Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardurion Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardurion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}, {'name': 'Imara, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}