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NCT Number: NCT01674777

A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941

This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.

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Key information

Conditions

Healthy Pharmacokinetics of ASP1941

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kantou, Japan

About this study

This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
  • Body weight ; ≥50.0 kg, <80.0 kg
  • Body Mass Index ; ≥17.6, <26.4
  • Written informed consent has been obtained

Exclusion criteria

  • Received any investigational drugs within 120 days before the screening assessment
  • Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment
  • Received medication within 7 days before hospital admission
  • A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
  • History of drug allergies
  • With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases

Treatment and study plan

ASP1941

Drug

oral

Other names: ipragliflozin

Primary outcomes

  1. Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax

    Time frame: For 72 hours after each administration

    Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)

Secondary outcomes

  1. Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance

    Time frame: For 72 hours after each administration

    Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 )

  2. Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests

    Time frame: For 72 hours after each administration

  3. Changes in urinary glucose excretion

    Time frame: Before and for 72 hours after each administration

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 29, 2012
Registry last updated
Aug 29, 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.

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