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

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