A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)

Study Overview
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Brief Summary
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A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.

Official Title
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A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild or Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK-0476

Conditions
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Asthma

Intervention / Treatment
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* Drug: Montelukast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between the ages of 18 and 65 Must have mild or moderate asthma (Part III only) Nonsmoker for at least 6 months Exclusion Criteria: History of stroke, chronic seizures or major neurological disorder You are nursing Drink more than 3 glasses of alcohol a day Have allergy to or not able to tolerate lactose Have a history of drug abuse in the last 5 years Drink more than 6 beverages containing caffeine a day Have had surgery, donated blood or participated in another investigational study in the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast 0.1 mg<br>Participants receive Montelukast inhalation powder, 0.1 mg. Part I: Administered as a single dose followed by at least a 3-day washout period. | Drug: Montelukast<br>* Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg<br>* Other names: MK-0476;|
| Experimental: Montelukast 0.3 mg<br>Participants receive Montelukast inhalation powder, 0.3 mg. Part I: Administered as a single dose followed by at least a 3-day washout period. | Drug: Montelukast<br>* Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg<br>* Other names: MK-0476;|
| Experimental: Montelukast 1 mg<br>Participants receive Montelukast inhalation powder, 1 mg. Part I: Administered as a single dose followed by at least a 3-day washout period. Part II: Administered once daily (QD) for 5 days followed by at least a 3-day washout period. | Drug: Montelukast<br>* Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg<br>* Other names: MK-0476;|
| Experimental: Montelukast 3 mg<br>Participants receive Montelukast inhalation powder, 3 mg. Part I: Administered as a single dose followed by at least a 3-day washout period. Part II: Administered QD for 5 days followed by at least a 3-day washout period. Part III: Administered QD for 10 days followed by at least a 7-day washout period. | Drug: Montelukast<br>* Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg<br>* Other names: MK-0476;|
| Experimental: Montelukast 10 mg<br>Participants receive Montelukast inhalation powder, 10 mg. Part I: Administered as a single dose followed by at least a 3-day washout period. Part II: Administered QD for 5 days followed by at least a 3-day washout period. Part III: Administered QD for 10 days followed by at least a 7-day washout period. | Drug: Montelukast<br>* Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg<br>* Other names: MK-0476;|
| Placebo Comparator: Placebo<br>Participants receive Placebo to Montelukast inhalation powder. Part I: Administered as a single dose followed by at least a 3-day washout period. Part II: Administered QD for 5 days followed by at least a 3-day washout period. Part III: Administered QD for 10 days followed by at least a 7-day washout period. | Drug: Placebo<br>* Placebo dry powder inhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced At Least One Adverse Event |  | Up to 14 days after last dose of study drug | 
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event |  | Up to 7 days after last dose of study drug | 
| Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose | Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. | Up to 24 hours postdose | 
| AUC 0-24hr of Montelukast - Multiple Doses | Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. | Up to 24 hours postdose | 
| Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose | Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. | Up to 24 hours postdose | 
| Cmax of Montelukast - Multiple Doses | Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. | Up to 24 hours postdose | 
| Time to Cmax (Tmax) of Montelukast - Single Dose | Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. | Up to 24 hours postdose | 
| Tmax of Montelukast - Multiple Doses | Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. | Up to 24 hours postdose | 
| Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose | Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. | Up to 24 hours postdose | 
| t1/2 of Montelukast - Multiple Doses | Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. | Up to 24 hours postdose | 
| AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses | The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III. | up to 10 days after first dose of study drug | 
| Cmax Accumulation Ratio of Montelukast - Multiple Doses | The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III. | up to 10 days after first dose of study drug |