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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01288885
First received: February 1, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Healthy
Drug: ASP1941
Drug: Placebo
Phase 1

Study Type: Interventional
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 76
Study Start Date: November 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ASP1941
    Oral
    Drug: Placebo
    Oral
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288885

Locations
United Kingdom
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT01288885     History of Changes
Other Study ID Numbers: 1941-CL-0001, 2006-002719-28
Study First Received: February 1, 2011
Last Updated: February 1, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
ASP1941
Diabetes Mellitus
First in Men

ClinicalTrials.gov processed this record on April 17, 2014