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

Astellas Pharma Inc48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

ASP1941DRUG

Oral

PlaceboDRUG

Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Groningen, Netherlands

Outcomes

Primary Outcomes

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

Pharmacokinetics assessed by the ASP1941 plasma concentration change

Time frame: up to 96 hours after last dose

Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine

Time frame: up to 96 hours after last dose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.