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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01403818
First received: July 25, 2011
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Healthy
Pharmacokinetics of ASP1941
Pharmacokinetics of Mitiglinide
Drug: ASP1941
Drug: Mitiglinide calcium hydrate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change [ Time Frame: For up to 72 hours after each administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests [ Time Frame: For up to 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change [ Time Frame: For 72 hours after ASP1941 administration ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1
Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
Drug: ASP1941
oral
Other Name: ipragliflozin
Drug: Mitiglinide calcium hydrate
oral
Other Name: Glufast
Experimental: Part 2
Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.
Drug: ASP1941
oral
Other Name: ipragliflozin
Drug: Mitiglinide calcium hydrate
oral
Other Name: Glufast

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403818

Locations
Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01403818     History of Changes
Other Study ID Numbers: 1941-CL-0074
Study First Received: July 25, 2011
Last Updated: October 10, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP1941
ipragliflozin
Mitiglinide calcium hydrate
Drug-Drug interaction
Pharmacokinetics

Additional relevant MeSH terms:
Calcium, Dietary
Mitiglinide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 27, 2014