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OpenTrials
Completed

NCT Number: NCT01288898

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

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.

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Key information

Conditions

Healthy Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Groningen, 9470 AE, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ASP1941

Drug

Oral

Placebo

Drug

Oral

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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 3, 2011
Registry last updated
Feb 3, 2011

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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