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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT01288885
• Lead Sponsor: Astellas Pharma Inc

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).

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 Timeline

• Study Start: 2006-11
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2011-02
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-01
• Last Update Submitted: 2011-02-01
• Study First Posted: 2011-02-03
• Last Update Posted: 2011-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacokinetics calculated by ASP1941 plasma concentration change	Up to 72 hours
Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine	Up to 72 hours