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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | 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 |
|
| Part 2 | Experimental | A single oral solution of 300 mg 14C-ODM-201 containing no more than 6.3 MBq (171 microCi) 14C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ODM-201 300 mg tablet | Drug |
| ||
| intravenous14C-ODM-201 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Metabolite profile of 14C-ODM-201 in plasma, urine and faeces | up to 14 days post-dose after oral solution dosing | |
| Maximum concentration (Cmax) of 14C-radioactivity in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing |
Key Inclusion Criteria:
Key exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Evans, MB ChB MRCS | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | NG11 6JS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34866168 | Derived | 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. |
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| ID | Term |
|---|---|
| C000607739 | darolutamide |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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|
| 300 mg 14C-ODM-201 oral solution | Drug |
|
| Time to maximum concentration (tmax) of 14C-radioactivity in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing |
| Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing |
| Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-radioactivity in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing |
| Half life (t1/2) of 14C-radioactivity in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing |
| Maximum concentration (Cmax) of ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Time to maximum concentration (tmax) of ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Area under the plasma concentration-time curve (AUC(0-t)) of ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Area under the plasma concentration-time curve (AUC(0-infinity)) of ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Half life (t1/2) of ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Maximum concentration (Cmax) of metabolite ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Time to maximum concentration (tmax) of metabolite ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Area under the plasma concentration-time curve (AUC(0-t)) of metabolite ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Area under the plasma concentration-time curve (AUC(0-infinity)) of metabolite ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Half life (t1/2) of metabolite ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing |
| Maximum concentration (Cmax) of metabolite 14C-ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Time to maximum concentration (tmax) of metabolite 14C-ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Area under the plasma concentration-time curve (AUC(0-t)) of metabolite 14C-ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Area under the plasma concentration-time curve (AUC(0-infinity)) of metabolite 14C-ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Half life (t1/2) of metabolite 14C-ORM 15341 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Maximum concentration (Cmax) of 14C-ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Time to maximum concentration (tmax) of 14C-ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Area under the plasma concentration-time curve (AUC(0-t)) of 14C-ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Half life (t1/2) of 14C-ODM-201 in plasma | The samples were taken 72 h post-dose after IV dosing |
| Maximum concentration (Cmax) of 14C-radioactivity in whole blood | The samples were taken 24 h post-dose after oral solution dosing |
| Time to maximum concentration (tmax) of 14C-radioactivity in whole blood | The samples were taken 24 h post-dose after oral solution dosing |
| Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in whole blood | The samples were taken 24 h post-dose after oral solution dosing |
| Renal elimination for ODM-201 in urine | The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing |
| Renal elimination for 14C-ODM-201 in urine | The samples were taken up-to 14 d post-dose after oral solution dosing |
| Fraction absorbed (FA) of total radioactivity based on urinary recovery of total radioactivity for both IV and oral dosing | The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing |
| Adverse events | Collected 7 days post-dose in part 1 and up to 14 days post-dose in part 2 |
| Physical examination | Full physical examination | 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) |
| Blood pressure | 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 |
| Heart rate | 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 |
| Oral temperature | 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 |
| 12-lead ECG | 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 |
| Clinical chemistry | Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin (Total), Calcium, Creatinine, Creatinine clearance, Lactate dehydrogenase, Potassium, Sodium and Urea | 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 |
| Haematology | Basophils, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes, MCH, MCHC, MCV, Monocytes, Neutrophils, Red Blood Cell Count, White Blood Cell Count and Thrombocytes | 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 |
| Urinalysis | Leucocytes, protein, erythrocytes, glucose and specific gravity | 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 |