Overview

Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Takeda
Treatments:
Alogliptin
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.