Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT02418650
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2015-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607739', 'term': 'darolutamide'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Metabolite profile of 14C-ODM-201 in plasma, urine and faeces', 'timeFrame': 'up to 14 days post-dose after oral solution dosing'}, {'measure': 'Maximum concentration (Cmax) of 14C-radioactivity in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing'}, {'measure': 'Time to maximum concentration (tmax) of 14C-radioactivity in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-radioactivity in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing'}, {'measure': 'Half life (t1/2) of 14C-radioactivity in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing'}, {'measure': 'Maximum concentration (Cmax) of ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Time to maximum concentration (tmax) of ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-t)) of ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-infinity)) of ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Half life (t1/2) of ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Maximum concentration (Cmax) of metabolite ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Time to maximum concentration (tmax) of metabolite ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-t)) of metabolite ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-infinity)) of metabolite ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Half life (t1/2) of metabolite ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing'}, {'measure': 'Maximum concentration (Cmax) of metabolite 14C-ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Time to maximum concentration (tmax) of metabolite 14C-ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-t)) of metabolite 14C-ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-infinity)) of metabolite 14C-ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Half life (t1/2) of metabolite 14C-ORM 15341 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Maximum concentration (Cmax) of 14C-ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Time to maximum concentration (tmax) of 14C-ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-t)) of 14C-ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Half life (t1/2) of 14C-ODM-201 in plasma', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing'}, {'measure': 'Maximum concentration (Cmax) of 14C-radioactivity in whole blood', 'timeFrame': 'The samples were taken 24 h post-dose after oral solution dosing'}, {'measure': 'Time to maximum concentration (tmax) of 14C-radioactivity in whole blood', 'timeFrame': 'The samples were taken 24 h post-dose after oral solution dosing'}, {'measure': 'Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in whole blood', 'timeFrame': 'The samples were taken 24 h post-dose after oral solution dosing'}, {'measure': 'Renal elimination for ODM-201 in urine', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing'}, {'measure': 'Renal elimination for 14C-ODM-201 in urine', 'timeFrame': 'The samples were taken up-to 14 d post-dose after oral solution dosing'}, {'measure': 'Fraction absorbed (FA) of total radioactivity based on urinary recovery of total radioactivity for both IV and oral dosing', 'timeFrame': 'The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing'}, {'measure': 'Adverse events', 'timeFrame': 'Collected 7 days post-dose in part 1 and up to 14 days post-dose in part 2'}, {'measure': 'Physical examination', 'timeFrame': 'Assessed at screening, pre-dose, at discharge from the study centre (72 h and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2)', 'description': 'Full physical examination'}, {'measure': 'Blood pressure', 'timeFrame': 'Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose'}, {'measure': 'Heart rate', 'timeFrame': 'Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose'}, {'measure': 'Oral temperature', 'timeFrame': 'Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose'}, {'measure': '12-lead ECG', 'timeFrame': 'Assessed at screening, pre-dose, 3 h, 5 h, 12 h, 24 h, 36 h and 48 h post-dose and at discharge from the study centre (72 h post-dose in part 1 and latest at 14 d post-dose in part 2) and in addition in part 1 7 d post-dose'}, {'measure': 'Clinical chemistry', 'timeFrame': 'Assessed at screening, pre-dose, 24 h and 48 h post-dose and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2', 'description': 'Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin (Total), Calcium, Creatinine, Creatinine clearance, Lactate dehydrogenase, Potassium, Sodium and Urea'}, {'measure': 'Haematology', 'timeFrame': 'Assessed at screening, pre-dose, 24 h and 48 h post-dose and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2', 'description': 'Basophils, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes, MCH, MCHC, MCV, Monocytes, Neutrophils, Red Blood Cell Count, White Blood Cell Count and Thrombocytes'}, {'measure': 'Urinalysis', 'timeFrame': 'Assessed at screening, pre-dose, 24 h and 48 h post-dose and 7 d post-dose in part 1 and latest at 14 d post-dose in part 2', 'description': 'Leucocytes, protein, erythrocytes, glucose and specific gravity'}], 'primaryOutcomes': [{'measure': 'Amount of 14C-ODM-201 dose excreted and cumulative amount excreted in urine and faeces and total. Amount excreted and cumulative amount excreted in urine, faeces and total expressed as a percentage of the administered dose.', 'timeFrame': 'Urine and faecal samples are collected baseline (Day-1) 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '34866168', 'type': 'DERIVED', 'citation': 'Zurth C, Nykanen P, Wilkinson G, Taavitsainen P, Vuorela A, Huang F, Reschke S, Koskinen M. Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment. Clin Pharmacokinet. 2022 Apr;61(4):565-575. doi: 10.1007/s40262-021-01078-y. Epub 2021 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.', 'detailedDescription': '6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy males\n* Aged 50 to 65 years (inclusive)\n* Normal weight defined as a body mass index (BMI) of \\>18.5 and \\<32.0 kg/m2\n* Weight 55 to 100 kg (inclusive)\n* Adequate method of contraception during the study and for a period of 6 months after study drug administration\n\nKey exclusion Criteria:\n\n* Evidence of clinically significant disease\n* Intake of any medication that could affect the outcome of the study\n* Known hypersensitivity to the active substances or the excipients of the drug or any serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients\n* History of anaphylactic/anaphylactoid reactions\n* Clinically significant abnormal biochemistry, haematology or urinalysis\n* Current or history of any drug or alcohol abuse in the past 2 years\n* Regular alcohol consumption \\>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)\n* Current use or use within the last 12 months of nicotine products\n* Positive drugs of abuse test result\n* Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results\n* Presence or history of clinically significant allergy requiring treatment'}, 'identificationModule': {'nctId': 'NCT02418650', 'acronym': 'ARIADME', 'briefTitle': 'Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': 'A Two-Part Open-Label, Single-Centre Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '3104005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'A single oral 300 mg tablet of ODM-201 followed by single intravenous 100 microg of 14C-ODM-201 containing not more than 37 kBq (1000 nCi)14C', 'interventionNames': ['Drug: ODM-201 300 mg tablet', 'Drug: intravenous14C-ODM-201']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'A single oral solution of 300 mg 14C-ODM-201 containing no more than 6.3 MBq (171 microCi) 14C', 'interventionNames': ['Drug: 300 mg 14C-ODM-201 oral solution']}], 'interventions': [{'name': 'ODM-201 300 mg tablet', 'type': 'DRUG', 'armGroupLabels': ['Part 1']}, {'name': 'intravenous14C-ODM-201', 'type': 'DRUG', 'armGroupLabels': ['Part 1']}, {'name': '300 mg 14C-ODM-201 oral solution', 'type': 'DRUG', 'armGroupLabels': ['Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Philip Evans, MB ChB MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Clinical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}