NCT01302132

Brief Summary

This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2008

Shorter than P25 for phase_1

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

May 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

5 months

First QC Date

February 21, 2011

Last Update Submit

February 21, 2011

Conditions

Healthy Subjects

Keywords

Mass BalanceASP1941Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of ASP1941 to evaluate metabolism and excretion

    up to 216 hours

Secondary Outcomes (1)

  • Identification of metabolic profile of ASP1941

    up to 216 hours

Interventions

ASP1941DRUG

Oral solution

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body weight between 60-100kg, BMI between 18.5-30 kg/m2, inclusive

You may not qualify if:

  • Pulse \<40 or \>90 bpm; Systolic Blood Pressure \> 140 mmHg; Diastolic Blood Pressure \>90 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zuidlaren, 9470 AE, Netherlands

Location

MeSH Terms

Interventions

ipragliflozin

Study Officials

  • Use Central Contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 21, 2011

First Posted

February 23, 2011

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

NL(1)