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

NCT01674777 | Completed Phase 1

• 1 other identifier: 1941-CL-0071
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Pharmacokinetics of ASP1941

Keywords

ASP1941; Food effect; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

  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)

  For 72 hours after each administration

Secondary Outcomes (3)

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

  For 72 hours after each administration

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

  For 72 hours after each administration

• Changes in urinary glucose excretion

  Before and for 72 hours after each administration

Study Arms (3)

under fasting condition group

EXPERIMENTAL

Subjects will receive a single dose of ASP1941 under fasting condition

Drug: ASP1941

before meal group

EXPERIMENTAL

Subjects will receive a single dose of ASP1941 before meal

Drug: ASP1941

after meal condition

EXPERIMENTAL

Subjects will receive a single dose of ASP1941 after meal

Drug: ASP1941

Interventions

ASP1941 DRUG

oral

Also known as: ipragliflozin

after meal condition; before meal group; under fasting condition group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kantou, Japan

Location

MeSH Terms

Interventions

ipragliflozin

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 29, 2012
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 29, 2012

Record last verified: 2012-08

Locations

JP (1)