A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration

Healthy Clinical Trial

Official title:

Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403818
• Other study ID #: 1941-CL-0074
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2011
• Last updated: October 10, 2011
• Start date: June 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• 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 assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.

Description:

This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• 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 kg/m2

• 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

• Previous treatment with ASP1941

Study Design

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

Related Conditions & MeSH terms

• Healthy
• Pharmacokinetics of ASP1941
• Pharmacokinetics of Mitiglinide

Intervention

Drug:
• ASP1941
oral
• Mitiglinide calcium hydrate
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 of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change		For up to 72 hours after each administration	No
Secondary	Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests		For up to 10 days	No
Secondary	Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change		For 72 hours after ASP1941 administration	No