Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT03400995
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2018-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707852', 'term': 'ziresovir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-16', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount excreted (Ae)', 'timeFrame': 'At approximately 6 weeks', 'description': 'The amount of total radioactivity eliminated.'}, {'measure': 'Percentage of the administered dose (%Ae)', 'timeFrame': 'At approximately 6 weeks', 'description': 'The amount of total radioactivity eliminated expressed as a percentage of the dose administered.'}, {'measure': 'Cumulative recovery (CumAe)', 'timeFrame': 'At approximately 6 weeks', 'description': 'The cumulative amount of total radioactivity eliminated.'}, {'measure': 'Percentage of cumulative recovery of the administered dose (Cum%Ae)', 'timeFrame': 'At approximately 6 weeks', 'description': 'The cumulative amount of total radioactivity eliminated expressed as a percentage of the dose administered.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects with Adverse Events (AEs)', 'timeFrame': 'From baseline up to approximately 6 weeks', 'description': 'An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This phase I study is to assess the mass balance recovery after a single oral dose of \\[14C\\]-AK0529 in healthy male subjects.', 'detailedDescription': 'This is a single centre, single-dose, non-randomised, open label study. The primary objectives of this study are to assess the mass balance recovery and provide biosamples for metabolite profiling and structural identification after a single oral dose of \\[14C\\]-AK0529 in healthy male subjects. 7 subjects will be recruited to receive a single oral administration of a solution containing 300 mg AK0529. The total duration of the study will be approximately 6 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy males\n* Aged between 30 and 55 years of age, inclusive\n* Body mass index of 18.0 to 35.0 kg/m2, inclusive, or, if outside the range, considered not clinically significant by the investigator and the medical monitor\n* Must be willing and able to communicate and participate in the whole study\n* Must have regular daily bowel movements\n* Must provide written informed consent\n* Must agree to use an adequate method of contraception\n\nExclusion Criteria:\n\n* Subjects who have received any IMP in a clinical research study within the previous 3 months\n* Subjects who are study site or sponsor employees, or immediate family members of a study site or sponsor employee\n* Subjects who have previously been enrolled in this study\n* History of any drug or alcohol abuse in the past 2 years\n* Regular alcohol consumption \\>21 units per week\n* Current smokers and those who have smoked within the last 12 months\n* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months\n* Radiation exposure. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study\n* Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening\n* Abnormal liver function as assessed by clinical chemistry\n* Positive drugs of abuse test result\n* Positive HBsAg, HCV Ab or HIV results\n* Evidence of renal impairment at screening\n* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, neurological, dermatological or GI disease, or psychiatric disorder, as judged by the investigator\n* Any abnormality of ECG parameters\n* Any abnormality of cardiac rhythm or history thereof\n* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients\n* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed, unless it is active at screening or admission\n* Donation or loss of greater than 400 mL of blood within the previous 3 months\n* Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal or any other 'alternative' remedies in the 14 days before IMP administration\n* Failure to satisfy the investigator of fitness to participate for any other reason"}, 'identificationModule': {'nctId': 'NCT03400995', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Ark Biopharmaceutical Co., Ltd.'}, 'officialTitle': 'An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-AK0529 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'AK0529-4001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Each subject will receive a single oral administration of a solution containing 300 mg radiolabeled AK0529 in the fasted state.', 'interventionNames': ['Drug: AK0529']}], 'interventions': [{'name': 'AK0529', 'type': 'DRUG', 'description': 'A solution containing 300 mg radiolabelled AK0529.', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'ArkBio Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'info@arkbiosciences.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Ark Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}