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

NCT01121198 | Completed Phase 1

• 1 other identifier: 1941-CL-0101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer; Pharmacokinetics of ASP1941

Keywords

Food effect

Outcome Measures

Primary Outcomes (1)

• Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests

  72 hours after drug administration

Secondary Outcomes (3)

• 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

Study Arms (4)

ASP1941 single arm

EXPERIMENTAL

Drug: ASP1941

ASP1941 repeated arm

EXPERIMENTAL

Drug: ASP1941

placebo single arm

PLACEBO COMPARATOR

Drug: placebo

placebo repeated arm

PLACEBO COMPARATOR

Drug: placebo

Interventions

ASP1941 DRUG

oral

ASP1941 repeated arm; ASP1941 single arm

placebo DRUG

oral

placebo repeated arm; placebo single arm

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kantou, Japan

Location

MeSH Terms

Interventions

ipragliflozin

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: December 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

JP (1)