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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01104532
Collaborator
(none)
64
Enrollment
1
Location
4
Arms
28
Duration (Days)
69.6
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Feb 1, 2010
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dosing Regimen 1

Drug: ASP1941
oral tablet

Drug: sitagliptin
oral tablet
Other Names:
  • Januvia

    		•
    Experimental: Dosing Regimen 2

    Drug: ASP1941
    oral tablet

    Drug: sitagliptin
    oral tablet
    Other Names:
  • Januvia

    		•
    Experimental: Dosing Regimen 3

    Drug: ASP1941
    oral tablet

    Drug: sitagliptin
    oral tablet
    Other Names:
  • Januvia

    		•
    Experimental: Dosing Regimen 4

    Drug: ASP1941
    oral tablet

    Drug: sitagliptin
    oral tablet
    Other Names:
  • Januvia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic variables assessment through analysis of blood samples [Day 1 to Day 15]

    Secondary Outcome Measures

    1. Pharmacodynamic variables assessment through analysis of blood and urine samples [Day -1 and up to Day 11]

    2. Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations [Day 1 through scheduled group check out (Day 11 and up to Day 15) or early termination.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Miami Florida United States 33014

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Director: Use Central Contact, Astellas Pharma Global Development

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01104532
    Other Study ID Numbers:
    • 1941-CL-0066
    First Posted:
    Apr 15, 2010
    Last Update Posted:
    Apr 16, 2010
    Last Verified:
    Apr 1, 2010
    Keywords provided by , ,
    ASP1941
    Januvia
    sitagliptin
    Additional relevant MeSH terms:
    Sitagliptin Phosphate
    Ipragliflozin

    Study Results

    No Results Posted as of Apr 16, 2010