NCT00960453

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

9 months

First QC Date

August 14, 2009

Last Update Submit

February 19, 2011

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Sitagliptin 25mg

OTHER

Repeated administrations for 4 days

Drug: Sitagliptin

Sitagliptin 50mg

OTHER

Repeated administrations for 4 days

Drug: Sitagliptin

Sitagliptin 100mg

OTHER

Repeated administrations for 4 days

Drug: Sitagliptin

Interventions

SitagliptinDRUG

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

Sitagliptin 100mgSitagliptin 25mgSitagliptin 50mg

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Center; Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Kyung-Sang Yu, MD, PhD

    Seoul National University College of Medicine and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

December 1, 2008

Primary Completion

September 1, 2009

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

KR(1)