A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects

ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01121198

Enrollment

Registered

2010-05-12

Start date

2006-12-31

Completion date

2007-07-31

Last updated

2010-05-12

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

Conditions

Healthy Volunteer, Pharmacokinetics of ASP1941

Keywords

Food effect

Brief summary

This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.

Detailed description

This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.

Interventions

DRUGASP1941

oral

DRUGplacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 44 Years

Healthy volunteers

Yes

Inclusion criteria

* Body weight: 50.0 kg ≤ weight \< 85.0 kg * Body mass index:17.6 ≤ BMI \< 26.4 * Those who provided written informed consent themselves

Exclusion criteria

* Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy * Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range * Those whose lab-test results are in the abnormal range * Those who received medical treatment within 14 days prior to the study * Those who attended another clinical study or a post-marketing clinical trial within 120 days before the study * Those who have received ASP1941 before * Those who have donated at least 400ml of whole blood within 90 days before the study, at least 200ml 30 days before the study or blood component within 14 days before the study * Those within a fasting plasma glucose level of \< 70mg/dL or 110 mg/dL or with an HbA1C. 5.8%

Design outcomes

Primary

Measure	Time frame
Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests	72 hours after drug administration

Secondary

Measure	Time frame
Plasma concentration of unchanged drug measured by blood sample	72 hours after drug administration
Blood glucose level measured by blood sample	72 hours after drug administration
Urinary glucose excretion level	72 hours after drug administration

Countries

Japan

Outcome results

None listed

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