A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in 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:
NCT00646789
First received: March 26, 2008
Last updated: May 6, 2009
Last verified: May 2009
  Purpose

To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate asthma patients to permit further clinical investigation.


Condition Intervention Phase
Asthma
Drug: Comparator: MK0633
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in 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. [ Time Frame: Blood and urine samples will be collected at specified intervals for 72 hours after study drug administration. ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: May 2008
Estimated Study Completion Date: June 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0633
Drug: Comparator: MK0633
patients will receive single 50mg oral dose with follow-up observation for 5 weeks.

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 and for 90 days after the last dose of study drug
  • 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, Singulair (montelukast), Xolair (omalizumab), Zyflo amd Zyflo CR (zileuton), oral corticosteroids and oral beta agonists are excluded approximately 2 weeks prior to administration of study drug and throughout the study
  • Patient consumes alcoholic beverages
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646789

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: NCT00646789     History of Changes
Other Study ID Numbers: 2008_514, MK0633-019
Study First Received: March 26, 2008
Last Updated: May 6, 2009
Health Authority: United States: Food and Drug Administration

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 14, 2014