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

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Astellas

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: ASP1941
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01288898
2006-006525-11 (EudraCT Number)
1941-CL-0002

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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