NCT01288885

Brief Summary

This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether the intake of food had an effect on the PK of ASP1941 (Part B).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2006

Typical duration 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

November 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
3.8 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

6 months

First QC Date

February 1, 2011

Last Update Submit

February 1, 2011

Conditions

Healthy

Keywords

ASP1941Diabetes MellitusFirst in Men

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

    Up to 2 weeks after each administration

Secondary Outcomes (2)

  • Pharmacokinetics calculated by ASP1941 plasma concentration change

    Up to 72 hours

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

    Up to 72 hours

Interventions

ASP1941DRUG

Oral

PlaceboDRUG

Oral

Eligibility Criteria

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

You may qualify if:

  • Body weight between 60-100 kg, 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%
  • Pulse \<40 or \>90 beats per minute; Systolic Blood Pressure (SBP) \<90 or \>140 mmHg; Diastolic Blood Pressure (DBP) \<40 or \>95mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Manchester, M15 6SH, United Kingdom

Location

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

November 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

February 3, 2011

Record last verified: 2011-02

Locations

GB(1)