Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants

NCT01391663 | Completed Phase 1 Results

• 2 other identifiers: SYR-322_106U1111-1121-7268
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics and Pharmacodynamics

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (6)

• Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter

  Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug

  Day 1-4, Day 10

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter

  Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug

  Day 1-4, Day 10.

• AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter

  Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.

  Day 1-4

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.

  Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.

  Day 1-4, Day 10.

• Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter

  Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.

  Day 1-4

• Oral Clearance (CL/F) Pharmacokinetic Parameter

  CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.

  Day 1-4

Study Arms (3)

Alogliptin 12.5 mg QD

EXPERIMENTAL

Drug: Alogliptin

Alogliptin 25 mg QD

EXPERIMENTAL

Drug: Alogliptin

Alogliptin 50 mg QD

EXPERIMENTAL

Drug: Alogliptin

Interventions

Alogliptin DRUG

Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.

Also known as: SYR-322

Alogliptin 12.5 mg QD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• 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.
• The participant is a healthy adult male or female participant of Korean descent.
• The participant is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
• The participant has a body mass index (BMI) between 18.0 and 26.0 kg/m2, inclusive at Screening.
• 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.
• 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.

You may not qualify if:

• The participant has received any investigational compound within 30 days prior to Screening.
• The participant has received alogliptin in a previous clinical study or as a therapeutic agent.
• 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.
• 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.
• Participant has a known hypersensitivity to any component of the formulation of alogliptin.
• The participant has a positive urine drug result for drugs of abuse or alcohol at Screening or Check-in (Day -1).
• 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.
• Participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.
• 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.
• If male, the participant intends to donate sperm during the course of this study or for 12 weeks after the last dose.
• 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.
• 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 \[e.g., cholecystectomy\]).
• Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
• 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.
• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Interventions

alogliptin

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Clinical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 22, 2013
• Results First Posted: March 22, 2013

Record last verified: 2013-02

Locations

KR (1)