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A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121198
First Posted: May 12, 2010
Last Update Posted: May 12, 2010
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 is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.

Condition Intervention Phase
Healthy Volunteer Pharmacokinetics of ASP1941 Drug: ASP1941 Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: ASP1941 Phase I Study —Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects—

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests [ Time Frame: 72 hours after drug administration ]

Secondary Outcome Measures:
  • Plasma concentration of unchanged drug measured by blood sample [ Time Frame: 72 hours after drug administration ]
  • Blood glucose level measured by blood sample [ Time Frame: 72 hours after drug administration ]
  • Urinary glucose excretion level [ Time Frame: 72 hours after drug administration ]

Enrollment: 84
Study Start Date: December 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 single arm Drug: ASP1941
oral
Experimental: ASP1941 repeated arm Drug: ASP1941
oral
Placebo Comparator: placebo single arm Drug: placebo
oral
Placebo Comparator: placebo repeated arm Drug: placebo
oral

Detailed Description:
This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body weight: 50.0 kg ≤ weight < 85.0 kg
  • Body mass index:17.6 ≤ BMI < 26.4
  • Those who provided written informed consent themselves

Exclusion Criteria:

  • Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy
  • Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range
  • Those whose lab-test results are in the abnormal range
  • Those who received medical treatment within 14 days prior to the study
  • Those who attended another clinical study or a post-marketing clinical trial within 120 days before the study
  • Those who have received ASP1941 before
  • Those who have donated at least 400ml of whole blood within 90 days before the study, at least 200ml 30 days before the study or blood component within 14 days before the study
  • Those within a fasting plasma glucose level of < 70mg/dL or 110 mg/dL or with an HbA1C. 5.8%
  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): NCT01121198


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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01121198     History of Changes
Other Study ID Numbers: 1941-CL-0101
First Submitted: May 10, 2010
First Posted: May 12, 2010
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by Astellas Pharma Inc:
Food effect


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