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)

NCT ID: NCT00646789

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-07-31

Brief Summary

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

MK0633

Group Type: EXPERIMENTAL

Comparator: MK0633

Intervention Type: DRUG

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

Interventions

Comparator: MK0633

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0633-019

Identifier Type: -

Identifier Source: secondary_id

2008_514

Identifier Type: -

Identifier Source: secondary_id

0633-019

Identifier Type: -

Identifier Source: org_study_id