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

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ClinicalTrials.gov Identifier: NCT01288885
Recruitment Status : Completed
First Posted : February 3, 2011
Last Update Posted : February 3, 2011
Sponsor:
Information provided by:
Astellas Pharma Inc

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).

Condition or disease Intervention/treatment Phase
Healthy Drug: ASP1941 Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
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
Study Start Date : November 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Intervention Details:
    Drug: ASP1941
    Oral
    Drug: Placebo
    Oral


Primary Outcome Measures :
  1. 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 :
  1. Pharmacokinetics calculated by ASP1941 plasma concentration change [ Time Frame: Up to 72 hours ]
  2. Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine [ Time Frame: Up to 72 hours ]


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
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

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


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.

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 Posted: February 3, 2011    Key Record Dates
Last Update Posted: February 3, 2011
Last Verified: February 2011

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