NCT02418650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

2 months

First QC Date

March 24, 2015

Last Update Submit

June 22, 2015

Conditions

Healthy

Keywords

volunteers

Outcome Measures

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.

    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 (41)

  • 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

  • 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

  • +38 more other outcomes

Study Arms (2)

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

Drug: ODM-201 300 mg tabletDrug: intravenous14C-ODM-201

Part 2

EXPERIMENTAL

A single oral solution of 300 mg 14C-ODM-201 containing no more than 6.3 MBq (171 microCi) 14C

Drug: 300 mg 14C-ODM-201 oral solution

Interventions

ODM-201 300 mg tabletDRUG
Part 1
intravenous14C-ODM-201DRUG
Part 1
300 mg 14C-ODM-201 oral solutionDRUG
Part 2

Eligibility Criteria

Age50 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34866168DERIVED

MeSH Terms

Interventions

darolutamideTablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Philip Evans, MB ChB MRCS

    Quotient Clinical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 16, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

GB(1)