A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol

A Phase I Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol.

This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Pharmacokinetics of ASP1941
• Intervention / Treatment: Drug: ASP1941; Drug: Miglitol

Detailed Description

This will be a randomized, open-label, 3-way crossover design study to assess the drug-drug interaction between a single oral dose of ASP1941 and a single oral dose of Miglitol in healthy adult male volunteers. Each subject will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol".

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kantou, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 blood 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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one group; Subjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.	Drug: ASP1941; oral; Drug: Miglitol; oral; Other Names: Seibule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples	For 72 hours after each administration

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: April 6, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Estimate): June 9, 2010
• Last Update Submitted That Met QC Criteria: June 8, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: ASP1941; Miglitol
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Sodium-Glucose Transporter 2 Inhibitors; Glycoside Hydrolase Inhibitors; Ipragliflozin; Miglitol
• Other Study ID Numbers: 1941-CL-0062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No