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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646789

Enrollment

Registered

2008-03-31

Start date

2008-05-31

Completion date

2008-07-31

Last updated

2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

Interventions

DRUGComparator: MK0633

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 16 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026