MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Drug: MK0633

Study type

Interventional

Funder types

Industry

Identifiers

NCT00768170

0633-028

MK0633-028

2008_552

Details and patient eligibility

About

This study evaluates the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate Japanese asthma patients to permit further clinical investigation

Enrollment

10 patients

Sex

All

Ages

12 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient Is Judged To Be In Good Health, Other Than Having Mild To Moderate Asthma, Based On Medical History, Physical Examination, Vital Signs, And Laboratory Safety Tests
Patient 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
Patient Has At Least 1 Year Of Mild-To-Moderate Asthma
Patient Has Been A Nonsmoker For At Least 6 Months
Patients Of Childbearing Potential Must Agree To Use A Medically Acceptable Method Of Contraception During The Study
Patients Must Be Able To Swallow Tablets

Exclusion criteria

Patient Has A History Of Clinically Significant Endocrine, Gastrointestinal, Cardiovascular, Hematological, Hepatic, Immunological, Renal, Respiratory, Other Than Asthma, Or Genitourinary Abnormalities Or Diseases
Patient Has Required A Visit To A Hospital Or Emergency Room Due To An Asthma Exacerbation Within 3 Months Of The Prestudy Visit
Patient Has Unresolved Signs And Symptoms Of An Upper Respiratory Tract Infection (Uri) Or Has Had Had An Upper Respiratory Tract Infection Within 3 Weeks Prior To The Prestudy Visit
Patient Has A History Of Stroke, Chronic Seizures, Or Major Neurological Disorder
Patient Has A History Of Neoplastic Disease
Use Of Theophylline, Anti-Allergic Compounds (Except For Nasal Drop And Eye-Drop Omalizumab, Zileuton, Oral Corticosteroid, And Oral Beta Agonists (Including Patch) Are Excluded ~ 2 Weeks Prior To Administration Of Study Drug And Throughout The Study 7)Patient Consumes Alcoholic Beverages