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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014