First in Men Study of Single Oral Doses of ASP1941 in Healthy Subjects

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01288885
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Duration (Months): 5.9
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether the intake of food had an effect on the PK of ASP1941 (Part B).

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

Detailed Description

This study consists of two parts. Part A is a double-blind, placebo controlled single dose escalation study to evaluate the safety and tolerability of single ascending doses of ASP1941. Part B is an open label, crossover design food-effect study to evaluate the effect of fed conditions on the PK of ASP1941.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 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, Pharmacokinetics, Pharmacodynamics and Food-effect of Single Oral Doses of ASP1941 in Healthy Male Subjects
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: May 1, 2007

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 [Up to 2 weeks after each administration]

Secondary Outcome Measures

1. Pharmacokinetics calculated by ASP1941 plasma concentration change [Up to 72 hours]

2. Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine [Up to 72 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Body weight between 60-100 kg, body mass index (BMI) between 20-30 kg/m2, inclusive

Exclusion Criteria:

• Fasting Plasma Glucose (FPG) > 6.4 mmol/l

• HbA1c > 6.2%

• Pulse <40 or >90 beats per minute; Systolic Blood Pressure (SBP) <90 or >140 mmHg; Diastolic Blood Pressure (DBP) <40 or >95mmHg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Manchester		United Kingdom	M15 6SH

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: NCT01288885
• Other Study ID Numbers: 1941-CL-0001; 2006-002719-28
• First Posted: Feb 3, 2011
• Last Update Posted: Feb 3, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: ASP1941; Diabetes Mellitus; First in Men
• Additional relevant MeSH terms: Ipragliflozin

Study Results

No Results Posted as of Feb 3, 2011