Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-03-10 @ 7:47 PM
Study NCT ID:
NCT02364635
Status:
COMPLETED
Last Update Posted:
2015-09-29
First Post:
2015-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Icosabutate - A Phase I, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626078', 'term': 'icosabutate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-28', 'studyFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic assessments of icosabutate - AUC', 'timeFrame': '0-36 hour', 'description': 'Exposure level of icosabutate measured as Area Under the Curve (AUC)'}, {'measure': 'Pharmacokinetic assessments of icosabutate - Cmax', 'timeFrame': '0-36 hour', 'description': 'Maximum observed plasma concentration of icosabutate (Cmax)'}, {'measure': 'Number of patients with Adverse Events', 'timeFrame': 'During the 36 hour assessment, and at post-study visit day 5-7', 'description': 'Clinically significant abnormalities found during the course of the study will be followed up until they return to normal or can be clinically explained'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I pharmacokinetics and safety study'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects\n\nObjective:\n\n* To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects\n* To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males of females\n* any ethnic origin\n* Age 18-55 years\n* BMI 18.0 - 33.0 kg/m2\n* generally in good health\n* signed informed consent\n\nExclusion Criteria:\n\n* males or females not willing to use appropriate contraception\n* recent blood donation\n* recent blood received\n* high consumption of alcohol\n* high consumption of tobacco\n* subjects who have engaged in heavy exercise last two weeks\n* prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety\n* other medication know to alter drug absorption or elimination\n* abnormal heart rate or blood pressure or 12-lead ECG\n* significant history of drug allergy, or hypersensitivity to treatment ingredients\n* ocular disorder requiring topical ocular therapy, or recent allergic eye disease\n* other significant medical history or physical findings'}, 'identificationModule': {'nctId': 'NCT02364635', 'briefTitle': 'Icosabutate - A Phase I, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pronova BioPharma'}, 'officialTitle': 'PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CTN401614104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Icosabutate dose 1', 'description': 'Dose 1', 'interventionNames': ['Drug: icosabutate']}, {'type': 'EXPERIMENTAL', 'label': 'Icosabutate dose 2', 'description': 'Dose 2', 'interventionNames': ['Drug: icosabutate']}, {'type': 'EXPERIMENTAL', 'label': 'Icosabutate dose 3', 'description': 'Dose 3', 'interventionNames': ['Drug: icosabutate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (medium chain triglycerides)', 'interventionNames': ['Drug: icosabutate']}, {'type': 'EXPERIMENTAL', 'label': 'Icosabutate dose 4', 'description': 'Dose 4', 'interventionNames': ['Drug: icosabutate']}], 'interventions': [{'name': 'icosabutate', 'type': 'DRUG', 'otherNames': ['PRC-4016'], 'description': 'Single dose at each dose levet', 'armGroupLabels': ['Icosabutate dose 1', 'Icosabutate dose 2', 'Icosabutate dose 3', 'Icosabutate dose 4', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Covance Clinical Research Unit (CRU) Ltd.', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Ashley Brooks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pronova BioPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}