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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01288898

Enrollment

Registered

2011-02-03

Start date

2007-05-31

Completion date

2008-03-31

Last updated

2011-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ASP1941, Diabetes Mellitus, Multiple ascending doses, Healthy subjects

Brief summary

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.

Interventions

DRUGASP1941

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests	31 days

Secondary

Measure	Time frame
Pharmacokinetics assessed by the ASP1941 plasma concentration change	up to 96 hours after last dose
Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine	up to 96 hours after last dose

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026