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

NCT01403818 | Completed Phase 1

• 1 other identifier: 1941-CL-0074
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.

Conditions

Healthy; Pharmacokinetics of ASP1941; Pharmacokinetics of Mitiglinide

Keywords

ASP1941; ipragliflozin; Mitiglinide calcium hydrate; Drug-Drug interaction; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change

  For up to 72 hours after each administration

Secondary Outcomes (2)

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

  For up to 10 days

• Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change

  For 72 hours after ASP1941 administration

Study Arms (2)

Part 1

EXPERIMENTAL

Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.

Drug: ASP1941; Drug: Mitiglinide calcium hydrate

Part 2

EXPERIMENTAL

Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.

Drug: ASP1941; Drug: Mitiglinide calcium hydrate

Interventions

ASP1941 DRUG

oral

Also known as: ipragliflozin

Part 1; Part 2

Mitiglinide calcium hydrate DRUG

oral

Also known as: Glufast

Part 1; Part 2

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 kg/m2
• 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
• Previous treatment with ASP1941

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: July 25, 2011
• First Posted: July 27, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

JP (1)