NCT00920998

Brief Summary

To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2009

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, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
Last Updated

July 20, 2009

Status Verified

July 1, 2009

Enrollment Period

3 months

First QC Date

June 15, 2009

Last Update Submit

July 16, 2009

Conditions

Healthy

Keywords

Z-338YM443healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of Z-338

    48 hours

Study Arms (1)

1. Z-338

EXPERIMENTAL

3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)

Drug: Z-338

Interventions

Z-338DRUG

oral

Also known as: YM443
1. Z-338

Eligibility Criteria

Age20 Years - 44 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subject
  • Body weight: 50.0 - 80.0 kg
  • BMI: 17.6 - 26.4

You may not qualify if:

  • Receiving an investigational new drug within 120 days of the study
  • Receiving medical treatment drugs within 7 days of the study
  • Blood donation before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

MeSH Terms

Interventions

Z 338

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 20, 2009

Record last verified: 2009-07

Locations

JP(1)