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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01121198
First received: May 10, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentration of unchanged drug measured by blood sample [ Time Frame: 72 hours after drug administration ] [ Designated as safety issue: No ]
  • Blood glucose level measured by blood sample [ Time Frame: 72 hours after drug administration ] [ Designated as safety issue: No ]
  • Urinary glucose excretion level [ Time Frame: 72 hours after drug administration ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 44 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121198

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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01121198     History of Changes
Other Study ID Numbers: 1941-CL-0101
Study First Received: May 10, 2010
Last Updated: May 10, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Food effect

ClinicalTrials.gov processed this record on September 18, 2014