Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-18 @ 7:55 AM
Study NCT ID:
NCT02852551
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2016-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-06-22', 'releaseDate': '2017-09-14'}], 'estimatedResultsFirstSubmitDate': '2017-09-14'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-28', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'one to seven days', 'description': 'Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'one to seven days'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve (AUC)', 'timeFrame': 'one to seven days'}, {'measure': 'Time to Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'one to seven days', 'description': 'Comparative pharmacokinetics of single dose administered in a fasted state and following a meal'}, {'measure': 'Terminal elimination half-life (t½)', 'timeFrame': 'one to seven days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.pharmakea.com', 'label': 'Sponsor Website'}]}, 'descriptionModule': {'briefSummary': 'A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive\n* body weight of 50 to 100 kg, inclusive\n* subjects must be in good health\n\nExclusion Criteria:\n\n* male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception\n* female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception\n* history of, any clinically significant major disorder\n* clinically significant allergic condition\n* significant history of alcoholism or drug/chemical abuse\n* use of any tobacco or nicotine-containing products\n* clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings\n* positive urine drugs of abuse screen or alcohol breath test'}, 'identificationModule': {'nctId': 'NCT02852551', 'briefTitle': 'Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'PharmAkea, Inc.'}, 'officialTitle': 'A Phase 1, Randomised, Placebo-Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of PAT-1251 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'PAT-1251-CL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAT-1251 Single Dose', 'description': 'Oral solution of PAT-1251, 150 - 4000 mg administered once', 'interventionNames': ['Drug: PAT-1251']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Single Dose', 'description': 'Matching placebo solution administered once', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PAT-1251 Multiple Dose', 'description': 'Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days', 'interventionNames': ['Drug: PAT-1251']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo Multiple Dose', 'description': 'Matching placebo tablets administered daily for 7 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PAT-1251', 'type': 'DRUG', 'armGroupLabels': ['PAT-1251 Multiple Dose', 'PAT-1251 Single Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo Multiple Dose', 'Placebo Single Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Covance Clinical Research Unit Ltd.', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Kevin Holme, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PharmAkea, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PharmAkea, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-09-14', 'type': 'RELEASE'}, {'date': '2018-06-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'PharmAkea, Inc.'}}}}