Healthy
Conditions
Keywords
volunteers
Brief summary
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.
Detailed description
6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively
Interventions
DRUGODM-201 300 mg tablet
DRUGintravenous14C-ODM-201
DRUG300 mg 14C-ODM-201 oral solution
Sponsors
Bayer
Orion Corporation, Orion Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy males * Aged 50 to 65 years (inclusive) * Normal weight defined as a body mass index (BMI) of \>18.5 and \<32.0 kg/m2 * Weight 55 to 100 kg (inclusive) * Adequate method of contraception during the study and for a period of 6 months after study drug administration Key
Exclusion criteria
* Evidence of clinically significant disease * Intake of any medication that could affect the outcome of the study * 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 * History of anaphylactic/anaphylactoid reactions * Clinically significant abnormal biochemistry, haematology or urinalysis * Current or history of any drug or alcohol abuse in the past 2 years * Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) * Current use or use within the last 12 months of nicotine products * Positive drugs of abuse test result * Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results * Presence or history of clinically significant allergy requiring treatment
Design outcomes
Primary
| Measure | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | 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) | Full physical examination |
| 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 | — |
| Metabolite profile of 14C-ODM-201 in plasma, urine and faeces | up to 14 days post-dose after oral solution dosing | — |
| 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 | 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 | Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin (Total), Calcium, Creatinine, Creatinine clearance, Lactate dehydrogenase, Potassium, Sodium and Urea |
| Haematology | 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 | Basophils, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes, MCH, MCHC, MCV, Monocytes, Neutrophils, Red Blood Cell Count, White Blood Cell Count and Thrombocytes |
| Urinalysis | 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 | Leucocytes, protein, erythrocytes, glucose and specific gravity |
| 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 | — |
Countries
United Kingdom
Outcome results
None listed