NCT01302158

Brief Summary

A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2009

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

December 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
11 months 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

4 months

First QC Date

February 21, 2011

Last Update Submit

February 21, 2011

Conditions

Healthy Subjects

Keywords

Drug-Drug interactionASP1941GlimepirideHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride

    14 days

Secondary Outcomes (1)

  • Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941

    14 days

Interventions

ASP1941DRUG

oral

GlimepirideDRUG

oral

Eligibility Criteria

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

You may qualify if:

  • BMI between 18.5 and 30 kg/m2, inclusive

You may not qualify if:

  • Any of the liver function tests above the upper limit of normal
  • 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

Groningen, 9470 AE, Netherlands

Location

MeSH Terms

Interventions

ipragliflozinglimepiride

Study Officials

  • Use Central Contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 21, 2011

First Posted

February 23, 2011

Study Start

December 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

NL(1)