First in Men Study of Single Oral Doses of ASP1941 in Healthy Subjects
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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|
- Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests [ Time Frame: Up to 2 weeks after each administration ] [ Designated as safety issue: No ]
- Pharmacokinetics calculated by ASP1941 plasma concentration change [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
- Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
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.