An Open-Label, Single- & Multiple-Dose Study to Investigate the Pharmacokinetics of Sitagliptin 100 mg in Healthy Chinese Adult Subjects (0431-108)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00642798
First received: March 7, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

To support the registration of sitagliptin 100mg in china.


Condition Intervention Phase
Diabetes Mellitus Non-insulin-dependent
Drug: sitagliptin phosphate
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single- & Multiple-Dose Study to Investigate the Pharmacokinetics of Sitagliptin 100 mg in Healthy Chinese Adult Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Pharmacokinetics of sitagliptin after administration of single and multiple 100-mg doses of sitagliptin to healthy chinese adult subjects. [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sitagliptin phosphate
    Sitagliptin 100mg once daily on Day 1 for single dose, and once daily on Day4-9 for multiple dose.
    Other Names:
    • Januvia™
    • MK0431
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject Has Been A Nonsmoker And/Or Has Not Used Nicotine Or Nicotine-Containing Products For At Least Approximately 6 Months; Subjects Who Have Discontinued Smoking Or The Use Of Nicotine/Nicotine Containing Products For At Least Approximately 3 Months May Be Enrolled In The Study At The Discretion Of The Investigator
  • Subject Has No Clinically Significant Abnormality On Electrocardiogram (Ecg) Performed At The Prestudy (Screening) Visit And/Or Prior To Administration Of The Initial Dose Of Study Drug
  • Subject Is Judged To Be In Good Health Based On Medical History, Physical Examination, Vital Sign Measurements, And Laboratory Safety Tests Performed At The Prestudy (Screening) Visit And/Or Prior To Administration Of The Initial Dose Of Study Drug
  • Subject Is Male Or Female 18 To 45 Years Of Age At The Prestudy (Screening) Visit. Female Subjects Of Reproductive Potential Must Demonstrate A Serum Beta-Hcg Level Consistent With The Nongravid State At The Prestudy (Screening) Visit And Agree To Use (And/Or Have Their Partner Use) Two Acceptable Methods Of Birth Control Beginning At Least 2 Weeks Prior To Administration Of The First Dose Of Study Drug, Throughout The Study (Including Washout Intervals Between Treatment Periods/Panels) And Until At Least 2 Weeks After Administration Of The Last Dose Of Study Drug In The Last Treatment Period. Acceptable Methods Of Birth Control Are: Abstinence, Intrauterine Device (Iud), Diaphragm, Spermicides, Cervical Cap, Contraceptive Sponge, And Condoms
  • Subject Is Of Chinese Descent With All 4 Biological Grandparents Born In China And Of Chinese Descent
  • Subject Is Willing To Comply With The Study Restrictions
  • Subject Understands The Study Procedures And Agrees To Participate In The Study By Giving Written Informed Consent
  • The Subject Has A Body Mass Index (BMI) Between 19 And 24 Kg/M2 And The Body Weight Is More Than 50 Kg At The Prestudy (Screening) Visit.

Exclusion Criteria:

  • Subject Consumes Excessive Amounts Of Alcohol, Defined As Greater Than 3 Glasses Of Alcoholic Beverages (1 Glass Is Approximately Equivalent To: Beer [284 Ml/10 Ounces],Wine [125 Ml/4 Ounces], Or Distilled Spirits [25 Ml/1 Ounce]) Per Day. Subjects That Consume 4 Glasses Of Alcoholic Beverages Per Day May Be Enrolled At The Discretion Of The Investigator
  • Subject Consumes Excessive Amounts, Defined As Greater Than 6 Servings (1 Serving Is Approximately Equivalent To 120 Mg Of Caffeine) Of Coffee, Tea, Cola, Or Other Caffeinated Beverages Per Day
  • Subject Has A History Of Any Illness That, In The Opinion Of The Study Investigator, Might Confound The Results Of The Study Or Poses An Additional Risk To The Subject By Their Participation In The Study
  • Subject Has A History Of Neoplastic Disease.
  • Subject Has A History Of Significant Multiple And/Or Severe Allergies, Or Has Had An Anaphylactic Reaction Or Significant Intolerability To Prescription Or Non-Prescription Drugs Or Food
  • Subject Has A History Of Stroke, Chronic Seizures, Or Major Neurological Disorder
  • Subject Has An Estimated Creatinine Clearance Of <=80 Ml/Min Based On The Cockcroft-Gault Equation
  • Subject Has Had Major Surgery, Donated Or Lost 1 Unit Of Blood (Approximately 500 Ml) Or Participated In Another Investigational Study Within 4 Weeks Prior To The Prestudy (Screening) Visit
  • Subject Is A Nursing Mother
  • Subject Is Currently A Regular User (Including Recreational Use)Of Any Illicit Drugs Or Has A History Of Drug (Including Alcohol) Abuse Within Approximately 6 Months
  • Subject Is Mentally Or Legally Incapacitated, Has Significant Emotional Problems At The Time Of Prestudy (Screening) Visit Or Expected During The Conduct Of The Study Or Has A History Of A Clinically Significant Psychiatric Disorder Over The Last 5 To 10 Years.Subjects Who Have Had Situational Depression May Be Enrolled In The Study At The Discretion Of The Investigator
  • Subject Is Unable To Refrain From Or Anticipates The Use Of Any Medication, Including Prescription And Non-Prescription Drugs Or Herbal Remedies (Such As St. John Wort[Hypericum Perforatum]) Beginning Approximately 2 Weeks (Or 5 Half-Lives) Prior To Administration Of The Initial Dose Of Study Drug, Throughout The Study (Including Washout Intervals Between Treatment Periods), Until The Post-study Visit
  • Subject Is Under The Age Of Legal Consent
  • There Is Any Concern By The Investigator Regarding The Safe Participation Of The Subject In The Study Or For Any Other Reason, The Investigator Considers The Subject Inappropriate For Participation In The Study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642798

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00642798     History of Changes
Other Study ID Numbers: 0431-108, 2008_002
Study First Received: March 7, 2008
Last Updated: February 27, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014