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)

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646789
• Other study ID #: 0633-019
• Secondary ID: MK0633-0192008_5
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2008
• Last updated: May 29, 2015
• Start date: May 2008
• Est. completion date: July 2008

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Comparator: MK0633
patients will receive single 50mg oral dose with follow-up observation for 5 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of MK0633 in adolescent asthma patients.		Blood and urine samples will be collected at specified intervals for 72 hours after study drug administration.	Yes