NCT01373060CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 56
- Primary Endpoint
- Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
ASP1941 group
Experimental
Intervention: ASP1941 (Drug)
placebo group
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG
Time Frame: up to 72 hours
Secondary Outcomes
- 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)
Investigators
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