Skip to main content
OpenTrials
Completed

NCT Number: NCT01611428

Absolute Bioavailability Study With Ipragliflozin

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bioavailability of Ipragliflozin Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ipragliflozin

Drug

Oral and Intravenous (i.v.)

Other names: ASP1941

Primary outcomes

  1. Assessment of the absolute bioavailability after a single oral dose of ipragliflozin

    Time frame: 6 days

Secondary outcomes

  1. 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)

  2. 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. 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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 5, 2012
Registry last updated
Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.