Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-29 @ 2:20 AM
Study NCT ID:
NCT04098692
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2019-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621805', 'term': 'derazantinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2019-09-19', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: Cmax', 'timeFrame': 'up to Day 50', 'description': 'Assessment of the maximum observed plasma concentration (Cmax)'}, {'measure': 'Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: Tmax', 'timeFrame': 'up to Day 50', 'description': 'Assessment of the time from dosing at which Cmax was apparent (Tmax)'}, {'measure': 'Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: t½', 'timeFrame': 'up to Day 50', 'description': 'Assessment of the apparent terminal elimination half-life (t½)'}, {'measure': 'Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: AUC0-t', 'timeFrame': 'up to Day 50', 'description': 'Assessment of the area under the concentration-time curve from dosing to the last measurable concentration (AUC0-t)'}, {'measure': 'Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: AUC0-inf', 'timeFrame': 'up to Day 50', 'description': 'Assessment of the area under the concentration-time curve from dosing extrapolated to infinity (AUC0-inf)'}, {'measure': 'Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: Tlast', 'timeFrame': 'up to Day 50', 'description': 'Assessment of the time of the last measurable (positive) concentration (Tlast)'}, {'measure': 'Assessment of the PK of [14C]-derazantinib: CL', 'timeFrame': 'up to Day 50', 'description': 'Assessment of the total clearance (CL)'}, {'measure': 'Assessment of the PK of [14C]-derazantinib: Vss', 'timeFrame': 'up to Day 50', 'description': 'Assessment of the volume of distribution at steady state (Vss)'}, {'measure': 'Assessment of the PK of [14C]-derazantinib: Vd', 'timeFrame': 'up to Day 50', 'description': 'Assessment of the volume of distribution (Vd)'}, {'measure': 'Assessment of the PK of derazantinib: CL/F', 'timeFrame': 'up to Day 50', 'description': 'Apparent total clearance (CL/F)'}, {'measure': 'Assessment of the PK of derazantinib: F', 'timeFrame': 'up to Day 50', 'description': 'Absolute bioavailability (F)'}, {'measure': 'Assessment of the rate and routes of excretion, and the mass balance of total radioactivity in urine and faeces and in all excreta', 'timeFrame': 'up to Day 50', 'description': 'Assessment of total radioactivity by measuring the amount excreted (Ae), Ae as a percentage of the administered dose (%Ae), cumulative recovery (CumAe), and cumulative recovery expressed as a percentage of the dose (Cum%Ae)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, two-part, open-label, single centre, single arm study in healthy male subjects to investigate the oral PK, intravenous (IV) PK, mass balance, bioavailability and metabolites profiling and identification of derazantinib.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy males\n* Age 18 to ≤ 55 years (Part 1)\n* Age 30 to ≤ 65 years (Part 2)\n* Body mass index of 18.0 to 29.0 kg/m² and a minimum body weight of 50 kg\n* Must have regular bowel movements\n* Must agree to adhere to the contraception requirements\n\nExclusion Criteria:\n\n* Male subjects with pregnant partners\n* Subjects who have received any investigational medicine in a clinical research study within the previous 3 months\n* Subjects who are study site employees, or immediate family members of a study site or sponsor employee\n* History of any drug or alcohol abuse in the 12 months prior to dosing\n* Regular alcohol consumption in males \\> 21 units per week\n* Smokers and users of e-cigarettes and nicotine replacement products and those who have used these products within the last 3 months\n* Radiation exposure (diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study\n* Participation in any study involving administration of any \\[14C\\]-labelled compound within 12 months prior to screening (Part 1 only)\n* Excessive caffeine consumption within 14 days prior to screening, defined as 800 mg per day (approximately 6 large cups of coffee)\n* Subjects who do not have suitable veins\n* Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the Investigator\n* Confirmed positive drugs of abuse test result\n* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results, or history of immunodeficiency diseases, including a positive HIV (ELISA and western blot) test result\n* Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of \\< 70 mL/min using the Cockcroft-Gault equation\n* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder or current clinical evidence of any corneal or retinal disorder\n* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active\n* Known hypersensitivity or allergy to natural rubber latex\n* History of any food allergies\n* History of clinically significant ECG abnormalities\n* Familial history of sick-sinus syndrome\n* Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction\n* Recent (within the last 3 years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma disease, treated or not treated)\n* History of malignancy of any organ system (other than localised basal cell carcinoma of the skin), treated or untreated, within the past 5 years\n* Use of any prescription drugs (including vaccines), herbal supplements (such as St. John's Wort, homeopathic preparations), within 4 weeks prior to initial dosing, and/or over-the-counter medication, dietary supplements (vitamins and minerals included) within 2 weeks prior to initial dosing\n* Donation or loss of 400 mL or more of blood and/or plasma within 3 months prior to initial dosing\n* Any history or presence of frequent episodes of diarrhoea (defined as an increase of 4 to 6 stools per day over usual individual defecation pattern).\n* Significant illness within 2 weeks prior to initial dosing\n* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardise the subject in case of participation in the study.\n\nNOTE: Other protocol defined Inclusion/ Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT04098692', 'briefTitle': 'Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Basilea Pharmaceutica'}, 'officialTitle': 'A Phase 1, Two-part, Open-label, Single-oral-dose Study to Investigate the Absolute Bioavailability and Absorption, Pharmacokinetics, Distribution, Metabolism, and Excretion of [14C]-Derazantinib in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'DZB-CS-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Arm: Derazantinib (Part 1 and Part 2)', 'description': '* Part 1: 300 mg Derazantinib oral administration followed by 100 μg \\[14C\\]-Derazantinib intravenous microdose\n* Part 2: 300 mg \\[14C\\]-Derazantinib oral administration', 'interventionNames': ['Drug: Derazantinib capsule', 'Drug: [14C]-Derazantinib solution for infusion', 'Drug: [14C]-Derazantinib capsule']}], 'interventions': [{'name': 'Derazantinib capsule', 'type': 'DRUG', 'description': '300 mg derazantinib oral administration (3x100 mg capsules)', 'armGroupLabels': ['Single-Arm: Derazantinib (Part 1 and Part 2)']}, {'name': '[14C]-Derazantinib solution for infusion', 'type': 'DRUG', 'description': '100 μg \\[14C\\]-derazantinib intravenous administration', 'armGroupLabels': ['Single-Arm: Derazantinib (Part 1 and Part 2)']}, {'name': '[14C]-Derazantinib capsule', 'type': 'DRUG', 'description': '300 mg \\[14C\\]-derazantinib oral administration (3x100 mg capsules)', 'armGroupLabels': ['Single-Arm: Derazantinib (Part 1 and Part 2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Sciences, Ruddington', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Nand Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basilea Pharmaceutica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}