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Completed

NCT Number: NCT00960453

Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trials Center; Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin

Drug

Dosage form: 25mg, 50mg ,100mg

Amount: 25mg, 50mg, 100mg

Frequency and duration: once a day, for 4 days, including 5 days washout periods

Primary outcomes

  1. To evaluate the pharmacokinetics after repeated administrations of sitagliptin 25, 50 and 100 mg

    Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration

  2. To evaluate the pharmacodynamics (activity of Dipeptidyl peptidase-IV enzyme) after repeated administrations of sitagliptin 25, 50 and 100 mg

    Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
First posted
Aug 17, 2009
Registry last updated
Feb 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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