Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 4:08 PM
Study NCT ID:
NCT05628961
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2022-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2022-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Adverse Events', 'timeFrame': 'Up to 14 days'}, {'measure': 'Number of Participants with One or More Drug-Related Adverse Events', 'timeFrame': 'Up to 14 days'}, {'measure': 'Number of Participants with One or More Adverse Events by Maximum Severity', 'timeFrame': 'Up to 14 days'}, {'measure': 'Number of Participants with One or More Serious Adverse Events', 'timeFrame': 'Up to 14 days'}], 'secondaryOutcomes': [{'measure': 'Observed Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Up to Day 7'}, {'measure': 'Observed Time to Reach Cmax (Tmax)', 'timeFrame': 'Up to Day 7'}, {'measure': 'Area Under the Plasma Concentration Time Curve up to the Last Blood Collection Time with a Measurable Concentration (AUClast)', 'timeFrame': 'Up to Day 7'}, {'measure': 'Extrapolated to Infinity (AUC0-inf)', 'timeFrame': 'Up to Day 7'}, {'measure': 'Terminal Half-Life (t 1/2)', 'timeFrame': 'Up to Day 7'}, {'measure': 'Apparent Volume of Distribution after Oral Administration (V/F)', 'timeFrame': 'Up to Day 7'}, {'measure': 'Oral Systemic Clearance Rate (CL/F)', 'timeFrame': 'Up to Day 7'}, {'measure': 'Cumulative Amount Excreted in Urine', 'timeFrame': 'Up to Day 7'}, {'measure': 'Cumulative Amount Excreted in Feces', 'timeFrame': 'Up to Day 7'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Internal Radionuclide Contamination'], 'conditions': ['Toxicity;Chemical']}, 'descriptionModule': {'briefSummary': 'The study objectives are to define the safety and tolerability profile of oral, single ascending dose (SAD) levels of HOPO 14-1 capsules in cohorts of healthy participants and to assess the pharmacokinetic (PK) and excretion profile of HOPO 14-1. The study hypothesis is that a single dose of HOPO 14-1 will be safe and tolerable up to 7500 mg.', 'detailedDescription': 'The currently available therapy for radionuclide internal contamination is suboptimal. Pharmacological and toxicological data support the clinical development of HOPO 14-1 for decorporation of radionuclides.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability of participant to understand the requirements of the study, provide written informed consent, and agree to abide by the study requirements\n* Agree to use contraception from time of screening until 14 days after dosing (Day 14) if female is of childbearing potential or male is with female partner of childbearing potential.\n* In good general health based on medical history, physical examination (PE), and screening evaluations.\n* Negative urine screen for drugs of abuse (except if participant provides prescription justifying use prior to urine screen).\n* Body weight ≥ 50 kilogram (kg) and ≤ 110 kg. If body weight is over 110 kg, then body mass index (BMI) will be considered and must be ≤ 40 kg/m\\^2.\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.\n* Any hematology, chemistry, coagulation, or urinalysis value on screening labs defined in the United States Food and Drug Administration (FDA) Guidance for Industry Toxicity Grading Scale as Grade 1 or higher.\n* Any clinically significant electrocardiogram (ECG) abnormality\n* Pregnant or breastfeeding\n* Active substance abuse or history of any medical or psychiatric condition that would jeopardize the participant's safety or the participant's ability to comply with the protocol.\n* Received an organ transplant (solid or bone marrow).\n* Received a blood transfusion within 3 months of dosing.\n* Difficulty swallowing tablets or capsules.\n* Febrile illness or significant infection within 7 days of dosing.\n* Symptoms of hypotension (lightheadedness, syncope, balance disturbances, or extreme fatigue) within 48 hours of dosing.\n* Hepatitis B virus surface antigen (HBsAg) positive or serologic (antibody positive) evidence of infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).\n* Tested positive for SARS-CoV-2 (COVID-19) within 21 days of dosing.\n* Chelation therapy (e.g., ethylenediaminetetraacetic acid \\[EDTA\\], diethylenetriamine pentaacetate \\[DTPA\\]) in the past year.\n* Use of laxatives, antibiotics, and/or antacids within 7 days of dosing.\n* Use of investigational drugs within 60 days of dosing or 5 half-lives, whichever is longer.\n* Received a vaccination within 30 days of dosing.\n* Potential allergic reaction to product (oleic acid or HOPO 14-1 product).\n* Past or current medical problems or findings from physical examination (PE) or laboratory testing"}, 'identificationModule': {'nctId': 'NCT05628961', 'briefTitle': 'Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'SRI International'}, 'officialTitle': 'An Open-Label, First-In-Human Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics, and Excretion in Healthy Participants', 'orgStudyIdInfo': {'id': 'SRI-HOPO-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: 100 mg', 'description': 'Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.', 'interventionNames': ['Drug: HOPO 14-1']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: 200 mg', 'description': 'Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.', 'interventionNames': ['Drug: HOPO 14-1']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: 500 mg', 'description': 'Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.', 'interventionNames': ['Drug: HOPO 14-1']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: 1200 mg', 'description': 'Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.', 'interventionNames': ['Drug: HOPO 14-1']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: 2500 mg', 'description': 'Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.', 'interventionNames': ['Drug: HOPO 14-1']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6: 5000 mg', 'description': 'Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.', 'interventionNames': ['Drug: HOPO 14-1']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 7: 7500 mg', 'description': 'Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.', 'interventionNames': ['Drug: HOPO 14-1']}], 'interventions': [{'name': 'HOPO 14-1', 'type': 'DRUG', 'description': 'HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.', 'armGroupLabels': ['Cohort 1: 100 mg', 'Cohort 2: 200 mg', 'Cohort 3: 500 mg', 'Cohort 4: 1200 mg', 'Cohort 5: 2500 mg', 'Cohort 6: 5000 mg', 'Cohort 7: 7500 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48170', 'city': 'Plymouth', 'state': 'Michigan', 'country': 'United States', 'facility': 'SRI International Clinical Trials Unit', 'geoPoint': {'lat': 42.37143, 'lon': -83.47021}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SRI International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}