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NCT Number: NCT01121198

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

This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.

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Key information

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kantou, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

ASP1941

Drug

oral

Placebo

Drug

oral

Primary outcomes

  1. Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests

    Time frame: 72 hours after drug administration

Secondary outcomes

  1. Plasma concentration of unchanged drug measured by blood sample

    Time frame: 72 hours after drug administration

  2. Blood glucose level measured by blood sample

    Time frame: 72 hours after drug administration

  3. Urinary glucose excretion level

    Time frame: 72 hours after drug administration

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 12, 2010
Registry last updated
May 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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