A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects

A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of ASP1941 in Healthy Male Taiwanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01373060

Enrollment

Registered

2011-06-14

Start date

2011-02-28

Completion date

2011-03-31

Last updated

2011-10-12

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

Conditions

Healthy, Pharmacokinetics of ASP1941

Keywords

ASP1941, ipragliflozin, plasma glucose, urine glucose

Brief summary

This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.

Detailed description

The subjects will be administered a single dose of ASP1941 or placebo under fasting condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate pharmacokinetic and pharmacodynamic properties of ASP1941.

Interventions

DRUGASP1941

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive

Exclusion criteria

* Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence * Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range * Labo test results deviate from preset normal range * Receiving treatment, including medication, within 14 days before the study * Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study * Donates 500mL of whole blood within 3 months or 250mL within 2 months or blood components within 14 days before the study * Drinking more than 45g of alcohol, or smoking more than 20 cigarettes per day * Employed by the sponsor, delegated CRO or the study site * Fasting plasma glucose level of \< 70 mg/dL or ≥110 mg/dL or with an HbA1c ≥5.8% * Subjects with positive serology test for Hepatitis B antigen, Hepatitis A virus IgM, anti-Hepatitis C virus or anti-Human Immunodeficiency virus-1 or -2

Design outcomes

Primary

Measure	Time frame
Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG	up to 72 hours

Secondary

Measure	Time frame
Cmax of ASP1941 plasma concentration	up to 72 hours
AUC (Area under the curve) of ASP1941 plasma concentration	up to 72 hours
Changes in plasma glucose	baseline and up to 72 hours
Changes in urine glucose	baseline and up to 72 hours

Countries

Taiwan

Outcome results

None listed

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