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)

NCT00646789 | Completed Phase 1

• 3 other identifiers: 0633-019MK0633-0192008_514
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

1

EXPERIMENTAL

MK0633

Drug: Comparator: MK0633

Interventions

Comparator: MK0633 DRUG

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

1

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 31, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 1, 2015

Record last verified: 2015-05