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

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01288898
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ASP1941; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: 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
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Outcome Measures

Primary Outcome Measures

1. Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests [31 days]

Secondary Outcome Measures

1. Pharmacokinetics assessed by the ASP1941 plasma concentration change [up to 96 hours after last dose]

2. Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine [up to 96 hours after last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Groningen		Netherlands	9470 AE

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Director: Use Central Contact, Astellas Pharma Europe B.V.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01288898
• Other Study ID Numbers: 1941-CL-0002; 2006-006525-11
• First Posted: Feb 3, 2011
• Last Update Posted: Feb 3, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: ASP1941; Diabetes Mellitus; Multiple ascending doses; Healthy subjects
• Additional relevant MeSH terms: Ipragliflozin

Study Results

No Results Posted as of Feb 3, 2011