Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects

Healthy Clinical Trial

— ARIADME  

Official title:

A Two-Part Open-Label, Single-Centre Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418650
• Other study ID #: 3104005
• Status: Completed
• Phase: Phase 1
• First received: March 24, 2015
• Last updated: June 22, 2015
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Administration of Radioactive Substances Advisory Committee (ARSAC)
• Study type: Interventional

Clinical Trial 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.

Description:

6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ODM-201 300 mg tablet

• intravenous14C-ODM-201

• 300 mg 14C-ODM-201 oral solution

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma	Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolite profile of 14C-ODM-201 in plasma, urine and faeces		up to 14 days post-dose after oral solution dosing	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	Maximum concentration (Cmax) of metabolite 14C-ORM 15341 in plasma		The samples were taken 72 h post-dose after IV dosing	No
Other	Time to maximum concentration (tmax) of metabolite 14C-ORM 15341 in plasma		The samples were taken 72 h post-dose after IV dosing	No
Other	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	No
Other	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	No
Other	Half life (t1/2) of metabolite 14C-ORM 15341 in plasma		The samples were taken 72 h post-dose after IV dosing	No
Other	Maximum concentration (Cmax) of 14C-ODM-201 in plasma		The samples were taken 72 h post-dose after IV dosing	No
Other	Time to maximum concentration (tmax) of 14C-ODM-201 in plasma		The samples were taken 72 h post-dose after IV dosing	No
Other	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	No
Other	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	No
Other	Half life (t1/2) of 14C-ODM-201 in plasma		The samples were taken 72 h post-dose after IV dosing	No
Other	Maximum concentration (Cmax) of 14C-radioactivity in whole blood		The samples were taken 24 h post-dose after oral solution dosing	No
Other	Time to maximum concentration (tmax) of 14C-radioactivity in whole blood		The samples were taken 24 h post-dose after oral solution dosing	No
Other	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	No
Other	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	No
Other	Renal elimination for 14C-ODM-201 in urine		The samples were taken up-to 14 d post-dose after oral solution dosing	No
Other	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	No
Other	Adverse events		Collected 7 days post-dose in part 1 and up to 14 days post-dose in part 2	Yes
Other	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)	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	Yes
Primary	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	No