MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00768170
First received: October 6, 2008
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Asthma
Drug: MK0633
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK0633 in Japanese Asthmatic Children Aged 12 to Less Than 16 Years

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the safety and tolerability of MK0633 in adolescent asthma patients based on any clinical or laboratory adverse experiences [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0633
Drug: MK0633
MK0633 (50 mg) Oral, single dose
Other Name: MK0633

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768170

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00768170     History of Changes
Other Study ID Numbers: 2008_552, MK0633-028
Study First Received: October 6, 2008
Last Updated: May 28, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014