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A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Sitagliptin When Given Together to Healthy Subjects

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.
ClinicalTrials.gov Identifier: NCT01104532
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : April 16, 2010
Information provided by:
Astellas Pharma Inc

Brief Summary:
The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and sitagliptin in single and multiple doses.

Condition or disease Intervention/treatment Phase
Healthy Pharmacokinetics of ASP1941 Drug: ASP1941 Drug: sitagliptin Phase 1

Detailed Description:
All subjects will be enrolled at one center and confined to the unit for up to 17 days. Subjects will be dosed in the fasting state in one of the four groups.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open Label, Randomized, Crossover, Drug Interaction Study of the Pharmacokinetics of ASP1941 and Sitagliptin After Separate and Concomitant Administration to Healthy Adult Subjects
Study Start Date : February 2010
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dosing Regimen 1 Drug: ASP1941
oral tablet
Drug: sitagliptin
oral tablet
Other Name: Januvia
Experimental: Dosing Regimen 2 Drug: ASP1941
oral tablet
Drug: sitagliptin
oral tablet
Other Name: Januvia
Experimental: Dosing Regimen 3 Drug: ASP1941
oral tablet
Drug: sitagliptin
oral tablet
Other Name: Januvia
Experimental: Dosing Regimen 4 Drug: ASP1941
oral tablet
Drug: sitagliptin
oral tablet
Other Name: Januvia

Primary Outcome Measures :
  1. Pharmacokinetic variables assessment through analysis of blood samples [ Time Frame: Day 1 to Day 15 ]

Secondary Outcome Measures :
  1. Pharmacodynamic variables assessment through analysis of blood and urine samples [ Time Frame: Day -1 and up to Day 11 ]
  2. Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations [ Time Frame: Day 1 through scheduled group check out (Day 11 and up to Day 15) or early termination. ]

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:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2 inclusive
  • The subject's 12-lead electrocardiogram (ECG) results are normal
  • The female subject must be at least two years postmenopausal, surgically sterile or practicing effective birth control and not pregnant or lactating
  • The male or female subject agrees to practice highly effective birth control from Screening until 7 days post last dose

Exclusion Criteria:

  • The subject has a history or evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
  • The subject has evidence of renal insufficiency (serum creatinine ≥ 1.5 in men and ≥ 1.3 in women)
  • The subject has a history of cholelithiasis or acute pancreatitis
  • The subject has any condition possibly affecting drug absorption (e.g., gastrectomy)
  • The subject has history of consuming more than 14 units of alcoholic beverages per week within last 6 months or has a history of alcoholism or drug/chemical/substance abuse within past 2 years or the subject tests positive for alcohol or drugs of abuse
  • The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in
  • The subject has a supine mean systolic blood pressure <90 or >160 mm/Hg and a mean diastolic blood pressure <50 or >90, or pulse rate higher than 100 beats per min (bpm)
  • The subject has a 12-lead ECG demonstrating QTcF >470 msec (female) or >450 msec (male)
  • The subject is known positive for human immunodeficiency virus (HIV) antibody
  • The subject has a positive test for tuberculosis (TB), hepatitis C antibody, or positive for hepatitis B surface antigen (HGsAg)
  • The subject has used prescription or non-prescription drugs within 14 days or 5 half-lives (whichever is longer) or complementary and alternative medicines (CAM) within 14 days prior to study drug administration (excluding oral contraceptives, hormone replacement therapy [HRT], and acetaminophen)
  • The subject has been vaccinated within the last 7 days
  • The subject has had any significant blood loss, donated one unit (450 mL) or blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission

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): NCT01104532

United States, Florida
Miami, Florida, United States, 33014
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Global Development

Responsible Party: Sr. Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01104532     History of Changes
Other Study ID Numbers: 1941-CL-0066
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: April 16, 2010
Last Verified: April 2010

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action