NCT01288898

Brief Summary

This study determined the safety of ASP1941 after a single and multiple once-daily doses for 10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 were assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
Last Updated

February 3, 2011

Status Verified

February 1, 2011

Enrollment Period

10 months

First QC Date

February 1, 2011

Last Update Submit

February 1, 2011

Conditions

Healthy

Keywords

ASP1941Diabetes MellitusMultiple ascending dosesHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests

    31 days

Secondary Outcomes (2)

  • Pharmacokinetics assessed by the ASP1941 plasma concentration change

    up to 96 hours after last dose

  • Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine

    up to 96 hours after last dose

Interventions

ASP1941DRUG

Oral

PlaceboDRUG

Oral

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body weight between 60-100kg, body mass index (BMI) between 20-30 kg/m2, inclusive

You may not qualify if:

  • Fasting Plasma Glucose (FPG) \> 6.4 mmol/l
  • HbA1c \> 6.2%
  • Abnormal pulse of blood pressure at screening, as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Groningen, 9470 AE, Netherlands

Location

Related Publications (1)

  • Veltkamp SA, Kadokura T, Krauwinkel WJ, Smulders RA. Effect of Ipragliflozin (ASP1941), a novel selective sodium-dependent glucose co-transporter 2 inhibitor, on urinary glucose excretion in healthy subjects. Clin Drug Investig. 2011 Dec 1;31(12):839-51. doi: 10.1007/BF03256922.

    PMID: 21877761DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

ipragliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Use Central Contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 3, 2011

Study Start

May 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 3, 2011

Record last verified: 2011-02

Locations

NL(1)