Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04819620
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2021-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of PN-232 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of PN-232', 'timeFrame': '10 days', 'description': 'Number and Severity of Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Peak concentration of PN-232 in plasma', 'timeFrame': '10 days', 'description': 'Peak concentration (Cmax) of PN-232'}, {'measure': 'Area under the Concentration (AUC) of PN-232', 'timeFrame': '10 days', 'description': 'AUC over 24 hours on Day 10 for PN-232'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that will be conducted in three parts. Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is crossover solid dose comparison and effect of food study.', 'detailedDescription': 'Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo as single doses.\n\nPart 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days.\n\nPart 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion.\n\nIn total, approximately 84 subjects will participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Subjects must have BMI between 18 and 32 kg/m2\n* Subjects must be non-smokers or social smokers\n* Subjects must comply with contraception requirements\n* Subjects must be willing to consume meals provided by the clinical center\n* Subjects must be willing to attend required clinic visits\n* Subjects must be suitable candidates for study procedures\n\nKey Exclusion Criteria:\n\n* Subject with a history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years\n* Subjects with a history of surgical resection of the stomach, small or large intestine\n* Subjects with a fever or symptomatic viral or bacterial infection within 2 weeks of screening or intestinal infection within 30 days prior to screening\n* Subjects with clinically significant laboratory abnormalities\n* Subjects with corrected QT greater than 450 msec in males and 470 msec in females\n* Subjects who test positive for Hepatitis C or B, or HIV at Screening\n* Subjects who cannot refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study\n* Subjects who test positive for drugs of abuse or alcohol at Screening'}, 'identificationModule': {'nctId': 'NCT04819620', 'briefTitle': 'Pharmacokinetics of PN-232 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Protagonist Therapeutics, Inc.'}, 'officialTitle': 'A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'PN-232-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Dose', 'description': 'Single dose administration', 'interventionNames': ['Drug: PN-232', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Dose', 'description': 'Multiple dose administration', 'interventionNames': ['Drug: PN-232', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Solid Dose Comparison', 'description': 'Solid dose administration', 'interventionNames': ['Drug: PN-232']}], 'interventions': [{'name': 'PN-232', 'type': 'DRUG', 'description': 'Active Drug', 'armGroupLabels': ['Multiple Dose', 'Single Dose', 'Solid Dose Comparison']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo', 'armGroupLabels': ['Multiple Dose', 'Single Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Protagonist Clinical Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Protagonist Study Site', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Protagonist Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}