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

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01121198
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 4
• Duration (Months): 7
• Patients Per Site Per Month: 12.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer; Pharmacokinetics of ASP1941	Drug: ASP1941; Drug: placebo	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Official Title: ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP1941 single arm	Drug: ASP1941; oral
Experimental: ASP1941 repeated arm	Drug: ASP1941; oral
Placebo Comparator: placebo single arm	Drug: placebo; oral
Placebo Comparator: placebo repeated arm	Drug: placebo; oral

Outcome Measures

Primary Outcome Measures

1. Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests [72 hours after drug administration]

Secondary Outcome Measures

1. Plasma concentration of unchanged drug measured by blood sample [72 hours after drug administration]

2. Blood glucose level measured by blood sample [72 hours after drug administration]

3. Urinary glucose excretion level [72 hours after drug administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 44 Years
• Sexes Eligible for Study: Male
• Accepts 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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kantou		Japan

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Chair: Use Central Contact, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01121198
• Other Study ID Numbers: 1941-CL-0101
• First Posted: May 12, 2010
• Last Update Posted: May 12, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: Food effect
• Additional relevant MeSH terms: Ipragliflozin

Study Results

No Results Posted as of May 12, 2010