Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:11 AM
Study NCT ID:
NCT07456059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-last', 'timeFrame': 'Day 1 to Day 13', 'description': 'Area under the plasma concentration time-curve from time zero to the last measured concentration'}, {'measure': 'AUC0-inf', 'timeFrame': 'Day 1 to Day 13', 'description': 'Area under the plasma concentration time-curve from time zero extrapolated to infinity'}, {'measure': 'AUCtau', 'timeFrame': 'Day 1 to Day 13', 'description': 'Area under the concentration-time curve during the dosing interval'}, {'measure': 'Cmax', 'timeFrame': 'Day 1 to Day 13', 'description': 'Maximum plasma concentration observed'}, {'measure': 'Cmax,ss', 'timeFrame': 'Day 1 to Day 13', 'description': 'Maximum plasma concentration at steady state determined directly from the concentration-time profile'}], 'secondaryOutcomes': [{'measure': 'Safety - TEAEs', 'timeFrame': 'Up to 23 days of monitoring', 'description': 'Incidence of treatment-emergent adverse events'}, {'measure': 'Tmax', 'timeFrame': 'Day 1 to Day 13', 'description': 'Time to maximum plasma concentration'}, {'measure': 'AUC%extrap', 'timeFrame': 'Day 1 to Day 13', 'description': 'Percentage of AUCinf obtained by extrapolation beyond time of the last quantifiable concentration (tlast)'}, {'measure': 'CL/F', 'timeFrame': 'Day 1 to Day 13', 'description': 'Total body clearance'}, {'measure': 'Vz/F', 'timeFrame': 'Day 1 to Day 13', 'description': 'Apparent volume of distribution'}, {'measure': 'T1/2', 'timeFrame': 'Day 1 to Day 13', 'description': 'Terminal elimination half-life'}, {'measure': 'Ctrough,ss', 'timeFrame': 'Day 1 to Day 13', 'description': 'Trough plasma concentration at steady state'}, {'measure': 'Cavg,ss', 'timeFrame': 'Day 1 to Day 13', 'description': 'Average plasma drug concentration during a dosing interval at steady state'}, {'measure': 'RA(AUCtau)', 'timeFrame': 'Day 1 to Day 13', 'description': 'Accumulation ratio for the area under the concentration-time curve during the dosing interval'}, {'measure': 'RA(Cmax)', 'timeFrame': 'Day 1 to Day 13', 'description': 'Accumulation ratio at the maximum concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult, male or female, 18-55 years of age, inclusive.\n* Medically healthy based on a medical evaluation (including medical history, physical examination, vital signs measurement, 12-lead ECG, and clinical laboratory evaluations) performed at screening.\n* Meets the protocol-specified criteria to qualify as a Japanese or Caucasian participant.\n* BMI ≥ 18.0 and ≤ 35.0 kg/m2 at screening.\n* Heart rate ≥ 45 and ≤ 99 bpm, systolic blood pressure ≥90 and \\<140 mmHg, and diastolic blood pressure ≥ 50 to ≤ 90 mmHg at screening.\n* eGFR ≥ 80 mL/min/1.73 m2 calculated using the CKD-EPI formula at screening.\n* Female and male participants must follow protocol-specified contraception guidance.\n\nExclusion Criteria:\n\n* History or evidence of any clinically significant cardiovascular, dermatologic, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, neurologic, psychiatric, pulmonary, renal, respiratory, and/or other major disorders or malignancy.\n* History or evidence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of drugs.\n* Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV).\n* History of significant blood loss, donation of blood, or received a transfusion of any blood or blood products within 60 days prior to screening.\n* History of plasma donation within 7 days prior to screening.\n* History of use of tobacco- or nicotine-containing products within six months prior to screening.\n* Participating in another interventional clinical study or has used an investigational drug within 30 days or 5 half-lives prior to screening.\n* History of alcohol and/or illicit drug abuse within 2 years of study participation.\n* Positive urine test for alcohol or a positive urine drug test at screening or check-in.\n* Breastfeeding or has a positive serum pregnancy test at screening or check-in.'}, 'identificationModule': {'nctId': 'NCT07456059', 'briefTitle': 'A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edgewise Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1, Single-center, Open-label, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Dose and Multiple Doses of EDG-7500 in Healthy Adult Caucasian and Japanese Participants', 'orgStudyIdInfo': {'id': 'EDG-7500-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - Healthy Japanese Adults', 'description': 'Single and Multiple Dose EDG-7500', 'interventionNames': ['Drug: EDG-7500']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - Healthy Japanese Adults', 'description': 'Single and Multiple Dose EDG-7500', 'interventionNames': ['Drug: EDG-7500']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 - Healthy Caucasian Adults', 'description': 'Single and Multiple Dose EDG-7500', 'interventionNames': ['Drug: EDG-7500']}], 'interventions': [{'name': 'EDG-7500', 'type': 'DRUG', 'description': 'Solid oral formulation of EDG-7500', 'armGroupLabels': ['Cohort 1 - Healthy Japanese Adults', 'Cohort 2 - Healthy Japanese Adults', 'Cohort 3 - Healthy Caucasian Adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Edgewise Therapeutics, Inc.', 'role': 'CONTACT', 'email': 'cardiacstudies@edgewisetx.com', 'phone': '720-262-7002'}], 'facility': 'Parexel', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'centralContacts': [{'name': 'Edgewise Therapeutics, Inc.', 'role': 'CONTACT', 'email': 'cardiacstudies@edgewisetx.com', 'phone': '720-262-7002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edgewise Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}