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

Astellas Pharma Inc76 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

ASP1941DRUG

Oral

PlaceboDRUG

Oral

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Manchester, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

Pharmacokinetics calculated by ASP1941 plasma concentration change

Time frame: Up to 72 hours

Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine

Time frame: Up to 72 hours

Data from ClinicalTrials.gov

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