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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674777
• Other study ID #: 1941-CL-0071
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2012
• Last updated: August 27, 2012
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy
• Pharmacokinetics of ASP1941

Intervention

Drug:
• ASP1941
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance	Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 )	For 72 hours after each administration	No
Secondary	Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests		For 72 hours after each administration	No
Secondary	Changes in urinary glucose excretion		Before and for 72 hours after each administration	No