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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01288885

Enrollment

Registered

2011-02-03

Start date

2006-11-30

Completion date

2007-05-31

Last updated

2011-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ASP1941, Diabetes Mellitus, First in Men

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.

Interventions

DRUGASP1941

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026