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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus Non-insulin-dependent

Treatments

Drug: sitagliptin phosphate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00642798

0431-108

2008_002

Details and patient eligibility

About

To support the registration of sitagliptin 100mg in china.

Enrollment

16 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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