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)
- Registration Number
- NCT00636207
- Lead Sponsor
- Organon and Co
- Brief Summary
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Montelukast 10 mg Montelukast 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. Montelukast 0.1 mg Montelukast Participants receive Montelukast inhalation powder, 0.1 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. Montelukast 0.3 mg Montelukast Participants receive Montelukast inhalation powder, 0.3 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. Placebo Placebo 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. Montelukast 1 mg Montelukast 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. Montelukast 3 mg Montelukast 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.
- Primary Outcome Measures
Name Time Method Cmax Accumulation Ratio of Montelukast - Multiple Doses up to 10 days after first dose of study drug 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.
Cmax of Montelukast - Multiple Doses Up to 24 hours postdose 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.
Time to Cmax (Tmax) of Montelukast - Single Dose Up to 24 hours postdose 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.
t1/2 of Montelukast - Multiple Doses Up to 24 hours postdose 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.
AUC 0-24hr of Montelukast - Multiple Doses Up to 24 hours postdose 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.
Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose Up to 24 hours postdose 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.
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 Up to 24 hours postdose 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.
Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose Up to 24 hours postdose 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.
Tmax of Montelukast - Multiple Doses Up to 24 hours postdose 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.
AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses up to 10 days after first dose of study drug 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.
- Secondary Outcome Measures
Name Time Method