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Completed

NCT Number: NCT02418650

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

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.

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Key information

Conditions

Healthy

Age range

50 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ODM-201 300 mg tablet

Drug

intravenous14C-ODM-201

Drug

300 mg 14C-ODM-201 oral solution

Drug

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Metabolite profile of 14C-ODM-201 in plasma, urine and faeces

    Time frame: up to 14 days post-dose after oral solution dosing

  2. Maximum concentration (Cmax) of 14C-radioactivity in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing

  3. Time to maximum concentration (tmax) of 14C-radioactivity in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing

  4. Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing

  5. Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-radioactivity in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing

  6. Half life (t1/2) of 14C-radioactivity in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing

  7. Maximum concentration (Cmax) of ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  8. Time to maximum concentration (tmax) of ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  9. Area under the plasma concentration-time curve (AUC(0-t)) of ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  10. Area under the plasma concentration-time curve (AUC(0-infinity)) of ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  11. Half life (t1/2) of ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  12. Maximum concentration (Cmax) of metabolite ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  13. Time to maximum concentration (tmax) of metabolite ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  14. Area under the plasma concentration-time curve (AUC(0-t)) of metabolite ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  15. Area under the plasma concentration-time curve (AUC(0-infinity)) of metabolite ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  16. Half life (t1/2) of metabolite ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 216 h post-dose after oral solution dosing

  17. Maximum concentration (Cmax) of metabolite 14C-ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  18. Time to maximum concentration (tmax) of metabolite 14C-ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  19. Area under the plasma concentration-time curve (AUC(0-t)) of metabolite 14C-ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  20. Area under the plasma concentration-time curve (AUC(0-infinity)) of metabolite 14C-ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  21. Half life (t1/2) of metabolite 14C-ORM 15341 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  22. Maximum concentration (Cmax) of 14C-ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  23. Time to maximum concentration (tmax) of 14C-ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  24. Area under the plasma concentration-time curve (AUC(0-t)) of 14C-ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  25. Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  26. Half life (t1/2) of 14C-ODM-201 in plasma

    Time frame: The samples were taken 72 h post-dose after IV dosing

  27. Maximum concentration (Cmax) of 14C-radioactivity in whole blood

    Time frame: The samples were taken 24 h post-dose after oral solution dosing

  28. Time to maximum concentration (tmax) of 14C-radioactivity in whole blood

    Time frame: The samples were taken 24 h post-dose after oral solution dosing

  29. Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in whole blood

    Time frame: The samples were taken 24 h post-dose after oral solution dosing

  30. Renal elimination for ODM-201 in urine

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing

  31. Renal elimination for 14C-ODM-201 in urine

    Time frame: The samples were taken up-to 14 d post-dose after oral solution dosing

  32. Fraction absorbed (FA) of total radioactivity based on urinary recovery of total radioactivity for both IV and oral dosing

    Time frame: The samples were taken 72 h post-dose after IV dosing and up-to 14 d post-dose after oral solution dosing

  33. Adverse events

    Time frame: Collected 7 days post-dose in part 1 and up to 14 days post-dose in part 2

  34. Physical examination

    Time frame: 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

  35. Blood pressure

    Time frame: 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

  36. Heart rate

    Time frame: 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

  37. Oral temperature

    Time frame: 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

  38. 12-lead ECG

    Time frame: 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

  39. Clinical chemistry

    Time frame: 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

  40. Haematology

    Time frame: 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

  41. Urinalysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study title

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

Acronym: ARIADME

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2015
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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