Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants
Condition: Pharmacokinetics and Pharmacodynamics
Intervention: Alogliptin; Alogliptin; Alogliptin
Intervention description: Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.; Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.; Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
Intervention MeSH terms: Alogliptin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of
      alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin in
      healthy Korean subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. The participant or, when applicable, the participant's legally acceptable
             representative signs and dates a written, informed consent form and any required
             privacy authorization prior to the initiation of any study procedures.

          3. The participant is a healthy adult male or female participant of Korean descent.

          4. The participant is aged 18 to 55 years, inclusive, at the time of informed consent and
             first study medication dose.

          5. The participant has a body mass index (BMI) between 18.0 and 26.0 kg/m2, inclusive at
             Screening.

          6. A male participant who is non-sterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 12 weeks after last the dose.

          7. A female participant of childbearing potential who is sexually active with a
             non-sterilized male partner agrees to use routinely adequate contraception from
             signing of informed consent throughout the duration of the study and for 30 days after
             the last dose of study drug.

        Exclusion Criteria:

          1. The participant has received any investigational compound within 30 days prior to
             Screening.

          2. The participant has received alogliptin in a previous clinical study or as a
             therapeutic agent.

          3. The participant is an immediate family member, study site employee, or in a dependant
             relationship with a study site employee who is involved in the conduct of this study
             (e.g., spouse, parent, child, sibling) or may consent under duress.

          4. The participant has history of uncontrolled, clinically significant manifestations of
             metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia),
             endocrine, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological,
             rheumatologic, skin and subcutaneous tissue disorders, infectious, hepatic, renal,
             urologic, immunologic, psychiatric or mood disorders (including any past history of
             suicide attempt), or a history of lactose intolerance, which may impact the ability of
             the participant to participate or potentially confound the study results.

          5. Participant has a known hypersensitivity to any component of the formulation of
             alogliptin.

          6. The participant has a positive urine drug result for drugs of abuse or alcohol at
             Screening or Check-in (Day -1).

          7. The participant has a history of drug abuse (defined as any illicit drug use) or a
             history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to
             agree to abstain from alcohol and drugs throughout the study.

          8. Participant has taken any excluded medication, supplements, or food products listed in
             the Excluded Medications and Dietary Products table.

          9. If female, the participant is pregnant or lactating or intending to become pregnant
             before, during, or within 30 days after participating in this study; or intending to
             donate ova during such time period.

         10. If male, the participant intends to donate sperm during the course of this study or
             for 12 weeks after the last dose.

         11. Participant 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 participant's medical history, physical examination, or safety
             laboratory tests giving reasonable suspicion of a disease that would contraindicate
             taking alogliptin, 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.

         12. Participant has current or recent (within 6 months) 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]).

         13. Participant has a history of cancer, except basal cell carcinoma which has been in
             remission for at least 5 years prior to Day 1.

         14. Participant has a positive test result for hepatitis B surface antigen (HBsAg),
             hepatitis C antibody (HCV), or a known history of human immunodeficiency virus
             infection at the Screening visit.

         15. Participant has used nicotine-containing products (including but not limited to
             cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28
             days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day
             -1).

         16. The participant has poor peripheral venous access.

         17. Participant has donated or lost 450 mL or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day
             1.

         18. Participant has a Screening or Check-in (Day -1) abnormal (clinically significant)
             electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically
             significant) ECG must be approved, and documented by signature by the principal
             investigator.

         19. Participant has abnormal Screening or Day -1 laboratory values that suggest a
             clinically significant underlying disease or participant with the following lab
             abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
             >2x the upper limits of normal.

         20. Participant has a hemoglobin value <12 g/dL at Screening only.

         21. Participant has a systolic blood pressure ≥140 mm Hg or has a diastolic blood pressure
             ≥90 mm Hg at Screening or Check-in (Day -1).

         22. Participant has a serum creatinine level >1.5 mg/dL at Screening only.