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CompletedNCT01288898Updated Feb 3, 2011

Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941

A Phase 1 interventional study of ASP1941 and Placebo in Healthy, sponsored by Astellas Pharma Inc. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-03.

Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

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Keywords

  • ASP1941
  • Diabetes Mellitus
  • Multiple ascending doses
  • Healthy subjects
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 48 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

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Lead sponsor

Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Fasting Plasma Glucose (FPG) > 6.4 mmol/l
  • HbA1c > 6.2%
  • Abnormal pulse of blood pressure at screening, as judged by the investigator
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

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

    Time frame: 31 days

Secondary outcomes

  1. Pharmacokinetics assessed by the ASP1941 plasma concentration change

    Time frame: up to 96 hours after last dose

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

    Time frame: up to 96 hours after last dose

07

Study locations

1 site
  • Groningen, 9470 AE, Netherlands
08

References and documents

Publications

  • 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. PubMed 21877761 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2007, a primary completion of Mar 2008 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2011
First posted
Feb 3, 2011
Start
May 2007
Primary completionActual
Mar 2008
CompletionActual
Mar 2008
Last update
Feb 3, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01288898
Lead sponsor
Astellas Pharma Inc
First posted
Feb 3, 2011
Start date
May 2007
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Feb 3, 2011

Study contacts

Use Central Contact
study director · Astellas Pharma Europe B.V.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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