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

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ASP1941

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01288885

1941-CL-0001

2006-002719-28 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

76 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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