A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years (0633-019)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00646789
First received: March 26, 2008
Last updated: June 26, 2014
Last verified: June 2014

March 26, 2008
June 26, 2014
May 2008
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00646789 on ClinicalTrials.gov Archive Site
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Not Provided
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A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years (0633-019)
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
Drug: Comparator: MK0633
patients will receive single 50mg oral dose with follow-up observation for 5 weeks.
Experimental: 1
MK0633
Intervention: Drug: Comparator: MK0633
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
12 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00646789
0633-019, MK0633-019, 2008_514
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP