Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects
Condition: Clinical Pharmacology
Intervention: SYR-322-MET
Intervention description: Oral administration of SYR-322-MET
Intervention MeSH terms: Alogliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, open-label, crossover study to determine the effect of food when a
      combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as
      SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after
      breakfast in Japanese healthy adult male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator or subinvestigator, the subject is capable of
             understanding and complying with protocol requirements.

          2. The subject signs and dates a written, informed consent form prior to the initiation
             of any study procedures.

          3. The subject is a Japanese healthy adult male.

          4. The subject is aged 20 to 35 years, inclusive, at the time of informed consent.

          5. The subject has a body weight of 50 kg or more with a BMI of ≥18.5 kg/m2 and <25.0
             kg/m2 at screening.

        Exclusion Criteria:

          1. The subject has received any investigational compound within 16 weeks (112 days) prior
             to the start of study drug administration in Period 1.

          2. The subject has received SYR-322 or metformin hydrochloride in a previous clinical
             study or as a therapeutic agent.

          3. The subject is an immediate family member, study site employee, or is in a dependant
             relationship with a study site employee who is involved in the conduct of this study
             (eg, spouse, parent, child, sibling) or may consent under duress.

          4. The subject has uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease
             or other abnormality, which may impact the ability of the subject to participate or
             potentially confound the study results.

          5. The subject has a known hypersensitivity to drugs.

          6. The subject has a positive urine drug result for drugs of abuse (defined as any
             illicit drug use) at screening.

          7. The subject has a history of drug abuse or history of alcohol abuse within 2 years
             prior to the screening visit or unwilling to agree to abstain from alcohol and drugs
             throughout the study.

          8. Subject has taken any excluded medication, supplements, or food products during the
             time periods listed in the Excluded Medications and Dietary Products table.

          9. Subject has evidence of current cardiovascular, central nervous system, hepatic,
             hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious
             allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash. There is
             any finding in the subject's medical history, physical examination, or safety
             laboratory tests giving reasonable suspicion of a disease that would contraindicate
             taking DPP-4 inhibitors or biguanides, or a similar drug in the same class, or that
             might interfere with the conduct of the study. This includes, but is not limited to,
             peptic ulcer disease, seizure disorders, and cardiac arrhythmias.

         10. The subject has current or recent [within 24 weeks (168 days) prior to the initiation
             of study treatment in Period 1] gastrointestinal disease that would be expected to
             influence the absorption of drugs (i.e., a history of malabsorption, esophageal
             reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week]
             occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]).

         11. The subject has a history of cancer.

         12. The subject has a positive test result for hepatitis B surface antigen (HBsAg),
             hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, or
             serological reactions for syphilis at screening.

         13. The subject has poor peripheral venous access.

         14. The subject has undergone whole blood collection of at least 200 mL within 4 weeks (28
             days) or at least 400 mL within 12 weeks (84 days) prior to the start of study
             medication administration Period 1.

         15. The subject has undergone whole blood collection of at least 800 mL in total within 52
             weeks (364 days) prior to the start of study medication administration in Period 1.

         16. The subject has undergone blood component collection within 2 weeks (14 days) prior to
             the start of study medication administration in Period 1.

         17. The subject has a screening or prior to the start of study medication administration
             on Day 1 in Period 1 hemoglobin level <12.5 g/dL.

         18. The subject has a screening or prior to the start of study medication administration
             on Day 1 in Period 1 abnormal (clinically significant) 12-lead ECG.

         19. Subject has abnormal screening or prior to the start of study medication
             administration on Day 1 in Period 1 laboratory values that suggest a clinically
             significant underlying disease or subject with the following lab abnormalities: ALT
             and/or AST >1.5 the upper limits of normal.

         20. Subject who, in the opinion of the investigator, is unlikely to comply with the
             protocol or is unsuitable for any other reason.