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OpenTrials
Completed

NCT Number: NCT00646789

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)

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: MK0633

Drug

patients will receive single 50mg oral dose with follow-up observation for 5 weeks.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 31, 2008
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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