Absolute Bioavailability Study With Ipragliflozin

May 31, 2012 updated by: Astellas Pharma Europe B.V.

A Single Dose, Open-label, Randomized Two-period Crossover Study in Healthy Young Subjects to Assess the Absolute Bioavailability of Ipragliflozin

A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ipragliflozin - oral
open label
Drug: Ipragliflozin
Oral and Intravenous (i.v.)
Other Names:
  • ASP1941
EXPERIMENTAL: Ipragliflozin - i.v.
open label
Drug: Ipragliflozin
Oral and Intravenous (i.v.)
Other Names:
  • ASP1941

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the absolute bioavailability after a single oral dose of ipragliflozin
Time Frame: 6 days
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of pharmacokinetics of ipragliflozin and its metabolite after a single oral dose and after an i.v. administration of ipragliflozin
Time Frame: 6 days
AUClast (Area under the plasma concentration-time curve up to the last quantifiable sample), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax)
6 days
Evaluation of the safety and tolerability of a single oral dose of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
Time Frame: 3 days
3 days
Evaluation of the safety and tolerability of an i.v. administration of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (ESTIMATE)

June 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1941-CL-0057
  • 2010-023813-77 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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