CClinicalTrials.gg
Sign In
CompletedNCT01118559Updated May 6, 2010

A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150

A Phase 1 interventional study of YM150 in Healthy and Pharmacokinetics of YM150, sponsored by Astellas Pharma Inc. Completed at 1 site in Japan. Open to male participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-06.

Sponsored by Astellas Pharma Inc · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
Male
01

Study summary

This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.

Read the detailed description

To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.

02

Conditions studied

  • Healthy
  • Pharmacokinetics of YM150

Keywords

  • YM150
  • Food effect
  • Healthy volunteer
03

In context

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body weight: ≥50.0 kg, \<80.0 kg
  • BMI: ≥17.6, \<26.4
  • Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests

Exclusion criteria

Exclusion Criteria:

  • Received any investigational drugs within 120 days before the study
  • Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
  • Received medication within 7 days before the study
  • A deviation from the assessment criteria of physical examinations or laboratory tests
  • A deviation from the normal reference range of coagulation test [PT or aPTT]
  • History of drug allergies
  • Upper gastrointestinal disease within 7 days before the study
  • Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
  • Concurrent or previous malignant tumor
  • Previous treatment with YM150
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    fast-fed sequence group

    drug is administered in a fasted condition first, and fed-condition study follows

    Drug: YM150

  • Experimental
    fed-fast sequence group

    drug is administered in a fed condition first, and fasted-condition study follows

    Drug: YM150

Interventions

  • DrugYM150

    oral

06

What researchers measure

Primary outcomes

  1. Plasma concentration of YM150 and its metabolites

    Time frame: for 3 days after drug administration

Secondary outcomes

  1. Safety assessed by AEs, vital signs, 12-lead ECG and lab tests

    Time frame: for 3 days after drug administration

  2. PT (prothrombin time)

    Time frame: for 3 days after drug administration

  3. aPTT (activated partial thromboplastin time)

    Time frame: for 2 days after drug administration

  4. FXa (factor Xa) activity

    Time frame: for 1 days after drug administration

07

Study locations

1 site
  • Kyushu, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01118559
Lead sponsor
Astellas Pharma Inc
First posted
May 6, 2010
Start date
Nov 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
May 6, 2010

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Astellas Pharma Inc

Start the discussion