Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-10 @ 8:33 AM
Study NCT ID:
NCT03185195
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582990', 'term': '4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-Label'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute bioavailability (F) of AQX-1125', 'timeFrame': '0 - 96 hrs'}, {'measure': 'Mass balance recovery of total radioactivity in urine, faeces and all excreta', 'timeFrame': '0 -168 hrs', 'description': 'Measure amount excreted (Ae)'}, {'measure': 'Mass balance recovery of total radioactivity in urine, faeces and all excreta', 'timeFrame': '0 -168 hrs', 'description': 'Measure Ae as a percentage of the administered dose (%Ae)'}, {'measure': 'Mass balance recovery of total radioactivity in urine, faeces and all excreta', 'timeFrame': '0 -168 hrs', 'description': 'Cumulative recovery of Ae (Cum Ae)'}, {'measure': 'Mass balance recovery of total radioactivity in urine, faeces and all excreta', 'timeFrame': '0 -168 hrs', 'description': 'Cum Ae expressed as a percentage of the administered dose (Cum %Ae)'}, {'measure': 'Metabolite profiling and structural identification in plasma, urine and faeces to estimate the routes and rates of elimination of [14-C]-AQX-1125', 'timeFrame': '0 -168 hrs'}, {'measure': 'Measure Ae total radioactivity for urine and faeces', 'timeFrame': '0-168 hrs'}, {'measure': 'Measure %Ae total radioactivity for urine and faeces', 'timeFrame': '0-168 hrs'}, {'measure': 'Measure Cum Ae (total) for urine and faeces', 'timeFrame': '0-168 hrs'}, {'measure': 'Measure Cum% Ae (total) for urine and faeces', 'timeFrame': '0-168 hrs'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration', 'timeFrame': '0 -96 hrs', 'description': 'Cmax'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'Tmax'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'Tlag'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'AUC (0-24)'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'AUC (0-last)'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'AUC (0-inf)'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'AUC % extrap'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'lambda-z'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'T1/2'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'CL/F'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'Vz/F'}, {'measure': 'Measure PK parameters of total radioactivity in plasma following oral administration:', 'timeFrame': '0 -96 hrs', 'description': 'MRT'}], 'secondaryOutcomes': [{'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of Cmax'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of Tmax'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of Tlag'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of AUC(0-24)'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of AUC(0-last)'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of AUC(0-inf)'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of AUC%extrap'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of lambda-z'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of T1/2'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of CL/F'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of Vz/F'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 1)', 'timeFrame': '0-96 hrs', 'description': 'Measurement of MRT'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of Cmax'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of Tmax'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of Tlag'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of AUC(0-24)'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of AUC(0-last)'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of AUC(0-inf)'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of AUC%extrap'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of lambda-z'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of T1/2'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of CL'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of Vz'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of VSS'}, {'measure': 'PK parameters of AQX-1125 in plasma following IV administration (Part 1)', 'timeFrame': '0 - 96 hrs', 'description': 'Measurement of MRT'}, {'measure': 'Safety and tolerability assessments based on adverse events, safety laboratory tests, vital signs, physical examinations, ECGs and AEs (Part 1)', 'timeFrame': '0 - 96 hrs'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of Cmax'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of Tmax'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of Tlag'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of AUC(0-24)'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of AUC(0-last)'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of AUC(0-inf)'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of AUC%extrap'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of lambda-z'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of T1/2'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of CL/F'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of Vz/F'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of F'}, {'measure': 'PK parameters of AQX-1125 in plasma following oral administration (Part 2)', 'timeFrame': '0 -168 hrs', 'description': 'Measurement of MRT'}, {'measure': 'Measure plasma whole blood concentration ratios for total radioactivity (Part 2)', 'timeFrame': '0 -168 hrs'}, {'measure': 'Chemical structure of major metabolites of [14-C]-AQX-1125', 'timeFrame': '0 -168 hrs', 'description': 'Major metabolites classified as \\>10% of the AUC of total radioactivity in plasma and \\>10% dose excreted in urine and faeces following oral administration (Part 2)'}, {'measure': 'Safety and tolerability assessments based on adverse events, safety laboratory tests, vital signs and ECG (Part 2)', 'timeFrame': '0 -168 hrs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This study is conducted to evaluate the absolute bioavailability, metabolism and elimination pathways of AQX-1125 in healthy male and female subjects.', 'detailedDescription': 'This is a single-centre, open-label, non-randomised, 2-part, sequential dose study in healthy male and female subjects. It is planned to enrol a single cohort of 8 healthy subjects (4 male and 4 female) who will participate in Part 1 and Part 2 of the study.\n\nIn Part 1, each subject will receive a single oral dose of AQX-1125 followed by an IV microtracer dose of carbon-14-AQX-1125 (\\[14C\\]-AQX-1125). In Part 2, each subject will receive a single oral dose of \\[14C\\]-AQX-1125.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males\n* Healthy females of non-child bearing potential\n* BMI 18.0 to 35 kg/m2\n\nExclusion Criteria:\n\n* History of any drug or alcohol abuse in the past 2 years\n* Regular alcohol consumption in males \\>21 units per week and females \\>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)\n* Current smokers and those who had smoked within the last 12 months; this included cigarettes, e-cigarettes and nicotine replacement products. Positive cotinine test result at screening and each admission\n* Clinically significant abnormal clinical chemistry, haematology, urinalysis or electrocardiogram (ECG)'}, 'identificationModule': {'nctId': 'NCT03185195', 'acronym': 'ADME', 'briefTitle': 'Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aquinox Pharmaceuticals (Canada) Inc.'}, 'officialTitle': 'An Open-Label,2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structure for [14C]-AQX-1125 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'AQX-1125-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AQX-1125 Oral Tablet', 'description': 'AQX-1125 - Oral Tablet', 'interventionNames': ['Drug: AQX-1125 Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': '[14C]-AQX-1125 IV', 'description': 'Radiolabelled AQX-1125 - Intravenous', 'interventionNames': ['Drug: [14C]-AQX-1125 IV']}, {'type': 'EXPERIMENTAL', 'label': '[14C]-AQX-1125 Oral Solution', 'description': 'Radiolabelled AQX-1125 - Oral Solution', 'interventionNames': ['Drug: [14C]-AQX-1125 Oral Solution']}], 'interventions': [{'name': 'AQX-1125 Oral Tablet', 'type': 'DRUG', 'description': 'Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \\[14C\\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \\[14C\\]-AQX-1125 oral solution.', 'armGroupLabels': ['AQX-1125 Oral Tablet']}, {'name': '[14C]-AQX-1125 IV', 'type': 'DRUG', 'otherNames': ['Radiolabelled AQX-1125 IV'], 'description': 'Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \\[14C\\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \\[14C\\]-AQX-1125 oral solution.', 'armGroupLabels': ['[14C]-AQX-1125 IV']}, {'name': '[14C]-AQX-1125 Oral Solution', 'type': 'DRUG', 'otherNames': ['Radiolabelled AQX-1125 Oral Solution'], 'description': 'Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \\[14C\\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \\[14C\\]-AQX-1125 oral solution.', 'armGroupLabels': ['[14C]-AQX-1125 Oral Solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Dr.Nand Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Clinical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aquinox Pharmaceuticals (Canada) Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quotient Clinical', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}