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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 3, 2011
Last Update Posted: February 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Astellas Pharma Inc
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
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • 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 ]

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
    Drug: Placebo
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288885

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

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 ( EudraCT Number )
First Submitted: February 1, 2011
First Posted: February 3, 2011
Last Update Posted: February 3, 2011
Last Verified: February 2011

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