Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin

Diabetes Mellitus Clinical Trial

Official title:

Multiple-dose, Dose Escalation Study to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960453
• Other study ID #: SNUCPT09_Sitagliptin
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2009
• Last updated: February 19, 2011
• Start date: December 2008

Study information

• Verified date: February 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of sitagliptin in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects aged 20 - 50 years

• A body mass index (BMI) in the range 17-28 kg/m2

• Fasting plasma glucose levels in the range 70-110 mg/dL

• Sufficient ability to understand the nature of the study and any hazards of participating in it

• Provide written informed consent after being fully informed about the study procedures

Exclusion Criteria:

• Presence or history of severe adverse reaction to any drug (e.g., sitagliptin) or a history of severe allergic disease

• Clinically relevant abnormal medical history that could interfere with the objectives of the study

• A subject who has the following screening laboratory test results; creatinine clearance (calculated by Cockcroft-Gault equation) < 80 mL/min

• History of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug

• A subject whose SBP is over 150 mmHg or below 100 mmHg and DBP is over 95 mmHg or below 65 mmHg

• Presence or history of drug abuse

• Participation in other clinical trial within 2 months

• Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose

• Blood donation during 2 months or apheresis during 1 month before the study

• Presence or history of alcohol abuse

• Users of nicotine-containing substances within the previous three months

• Use of grapefruit juice, alcohol or smoking during restriction period

• Subject judged not eligible for study participation by investigator

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
Dosage form: 25mg, 50mg ,100mg Amount: 25mg, 50mg, 100mg Frequency and duration: once a day, for 4 days, including 5 days washout periods

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trials Center; Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pharmacokinetics after repeated administrations of sitagliptin 25, 50 and 100 mg		Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration	No
Primary	To evaluate the pharmacodynamics (activity of Dipeptidyl peptidase-IV enzyme) after repeated administrations of sitagliptin 25, 50 and 100 mg		Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration	No