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A Study to Find Out How YM150 is Absorbed Into and Eliminated From the Body in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01657981
First received: July 10, 2012
Last updated: June 24, 2013
Last verified: August 2012
  Purpose

The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with a radio labeled drinking solution.


Condition Intervention Phase
Pharmacokinetics
Healthy Male Subjects
Drug: YM150
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open Label Study to Evaluate the Pharmacokinetics of YM150 After a Single Oral Dose of C14-labeled YM150 in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetics of 14C-labeled YM150 assessed by whole blood, plasma, urine, feces and expired air concentrations [ Time Frame: Day 1 - Day 6 ] [ Designated as safety issue: No ]
    AUCinf (Amount excreted in urine extrapolated until infinity), AUClast (Amount excreted in urine until last sample), Cmax (Maximum concentration), tmax (Time to attain maximum concentration), tlag (Absorption lag time) and t1/2 (Apparent terminal elimination half-life). Excretion rate and cumulative excretion of radioactivity in urine, feces and expired air.

  • Pharmacokinetics of YM150 and metabolites assessed by plasma and urine concentrations [ Time Frame: Day 1 - Day 6 ] [ Designated as safety issue: No ]
    - AUCinf, AUClast, Cmax, tmax, tlag and t1/2. In urine - amount excreted in urine, CLR (Renal clearance) and % of dose excreted.


Secondary Outcome Measures:
  • Identification of the metabolic profile of YM150 in human plasma, urine and feces [ Time Frame: 0 - 2 hours Day 1 ] [ Designated as safety issue: No ]
  • Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events [ Time Frame: Day 1 - 14 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2007
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm 1 Drug: YM150
14C-labeled YM150, oral solution
Other Name: darexaban

Detailed Description:

Healthy male subjects are admitted on Day 0. Subjects receive a single oral dose of 14C-labeled YM150 in the morning of Day 1 and remain in the unit for 7 days (6 nights). Blood, plasma, urine and feces samples are collected until 120 hrs after dosing for analysis of 14C-labeled radioactivity, YM150, YM-222714 and other metabolites. Expired air is collected as well for assessment of 14C-radioactivity.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body weight between 60 and 100 kg and Body Mass Index between 18 and 30 kg/m2

Exclusion Criteria:

  • Known or suspected hypersensitivity to YM150 or any of the constituents of the formulations used
  • History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia, including but not limited to neutropenia, thrombocytopenia, thrombocytopathy, thromboasthenia, hemophilia, Von Willebrand's disease, and vascular purpura, bleeding gums or frequent nose bleeding
  • Family history of congenital vascular malformation (e.g. Marfan's Syndrome) and/or bleeding disorder (e.g. hemophilia, Von Willebrand's disease, Christmas disease)
  • History of peptic ulcer or of any other organic lesion susceptible to bleeding
  • Prothrombin time (PT) or Activated partial thromboplastin time (aPTT) at the screening visit outside the normal range
  • Any surgical intervention (including tooth extraction) or trauma within the last 3 months preceding the start of the study
  • Any clinically significant history of asthma, eczema, any other clinically significant allergic condition or previous severe hypersensitivity to any other drug
  • Any clinically significant upper gastro-intestinal symptoms likely to interfere with the absorption of the drug
  • History or presence of any cardiovascular disease or disorder
  • History of a clinically significant ECG abnormality
  • Any clinically relevant history of other disease or disorder - gastrointestinal, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
  • Any clinically significant abnormality following the Investigator's review of the pre-study physical examination, ECG, and clinical laboratory tests
  • Abnormal heart rate and blood pressure measurements at the screening visit as follows: heart rate <40 or >90 bpm; mean systolic blood pressure <95 or >160 mmHg; mean diastolic blood pressure <40 or >95 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min)
  • Regular use of any prescribed or OTC drugs (including vitamins and herbal remedies) in the 4 weeks prior to admission to the clinical unit OR any use of such drugs in the 2 weeks prior to admission to the clinical unit
  • History of drug abuse at any time, OR any use of drugs of abuse within 3 months prior to admission to the clinical unit
  • Participation in any clinical study within 3 months, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study
  • History of drinking more than 21 units of alcohol per week (1 unit = 270 ml of beer or 40 ml of spirits or 125 ml of wine) within 3 months prior to admission to the clinical unit
  • History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit
  • Subject, who is anti-HAV (IgM), anti-HCV, HBsAg or HIV-1 or -2 positive
  • Donation of blood (>400 ml) or blood products within 3 months prior to admission to the clinical unit or plasmapheresis within 4 weeks prior to admission to the clinical unit
  • Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657981

Locations
Netherlands
PRA International EDS NL
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01657981     History of Changes
Other Study ID Numbers: 150-CL-015, 2006-001968-22
Study First Received: July 10, 2012
Last Updated: June 24, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Astellas Pharma Inc:
Pharmacokinetics
Phase 1
14C-labeled

ClinicalTrials.gov processed this record on November 27, 2014