Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT03886103
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2019-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Metabolism of (14C)-Labelled PXL770
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass balance recovery', 'timeFrame': 'From day 1 to day 7', 'description': 'Mass balance recovery of total radioactivity in all excreta: cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)'}], 'secondaryOutcomes': [{'measure': 'PK profile of total radioactivity', 'timeFrame': 'From day 1 to day 7', 'description': 'Cmax'}, {'measure': 'PK profile of PXL770', 'timeFrame': 'From day 1 to day 7', 'description': 'Cmax'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'From day 1 to day 7', 'description': 'Incidence of Treatment-Emergent Adverse Events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Caucasian males\n* Age 30 to 65 years\n* BMI 18.5 to 32.0 kg/m2 and body weight of 55 to 95 kg.\n* Must be willing and able to communicate and participate in the whole study\n* Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)\n* Must provide written informed consent\n* Regular alcohol consumption of 4-14 units of alcohol per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)\n* Must agree to adhere to the contraception\n\nExclusion Criteria:\n\n* Subjects who have received any IMP in a clinical research study within the previous 3 months or 90 days prior to Day 1\n* any drug or alcohol abuse\n* Current smokers and those who have smoked within the last 12 months.\n* Radiation exposure, including that from the present study, excluding background adiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.\n* No occupationally exposedworker, as defined in the Ionizing Radiation Regulations 2017, shall participate in the study\n* Clinically significant abnormal biochemistry, hematology, coagulation or urinalysis as judged by the investigator\n* Positive test for HIV, HBV, HBC\n* eGFR \\<80 mL/min\n* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator\n* Known sensitivity to any of the constituents or excipients of the study drug or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions)\n* History of drug-induced Torsade de Pointe or presence of a familial long QT syndrome\n* Mental handicap'}, 'identificationModule': {'nctId': 'NCT03886103', 'briefTitle': 'Pharmacokinetics and Metabolism of (14C)-Labelled PXL770', 'organization': {'class': 'INDUSTRY', 'fullName': 'Poxel SA'}, 'officialTitle': 'Pharmacokinetics and Metabolism of [14C]-Labelled PXL770 Following a Single Oral Administration in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'PXL770-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteer', 'description': 'Single of 14C-PXL770', 'interventionNames': ['Drug: 14C labeled PXL770']}], 'interventions': [{'name': '14C labeled PXL770', 'type': 'DRUG', 'description': 'Single administration', 'armGroupLabels': ['Healthy volunteer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poxel SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}