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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288898
First Posted: February 3, 2011
Last Update Posted: February 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Astellas Pharma Inc
  Purpose
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.

Condition Intervention Phase
Healthy Drug: ASP1941 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of ASP1941 and to Explore the Effect of ASP1941 on Urine and Blood Glucose Levels in Healthy Subjects

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Pharmacokinetics assessed by the ASP1941 plasma concentration change [ Time Frame: up to 96 hours after last dose ]
  • Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine [ Time Frame: up to 96 hours after last dose ]

Enrollment: 48
Study Start Date: May 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ASP1941
    Oral
    Drug: Placebo
    Oral
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288898


Locations
Netherlands
Groningen, Netherlands, 9470 AE
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT01288898     History of Changes
Other Study ID Numbers: 1941-CL-0002
2006-006525-11 ( EudraCT Number )
First Submitted: February 1, 2011
First Posted: February 3, 2011
Last Update Posted: February 3, 2011
Last Verified: February 2011

Keywords provided by Astellas Pharma Inc:
ASP1941
Diabetes Mellitus
Multiple ascending doses
Healthy subjects