Drug to Drug Interaction Study With Ipragliflozin and Furosemide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-10-31

Brief Summary

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A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions between furosemide and ipragliflozin (ASP1941) in healthy volunteers.

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Detailed Description

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Conditions

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Healthy Subjects Pharmacokinetics of Ipragliflozin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ipragliflozin

Group Type EXPERIMENTAL

Ipragliflozin

Intervention Type DRUG

Oral

furosemide

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Oral

ipragliflozin & furosemide

Group Type EXPERIMENTAL

Ipragliflozin

Intervention Type DRUG

Oral

Furosemide

Intervention Type DRUG

Oral

Interventions

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Ipragliflozin

Oral

Intervention Type DRUG

Furosemide

Oral

Intervention Type DRUG

Other Intervention Names

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ASP1941

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria

* Any of the liver function tests above the upper limit of normal
* Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse \<40 or \>90 bpm; mean systolic blood pressure \>140 mmHg; mean diastolic blood pressure \>90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
* A QTc interval of \>430 ms (males) or \> 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes