Phase 1
N=46
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)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00636207 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Number of Participants Who Experienced At Least One Adverse Event — 2; 4; 6; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Montelukast (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced At Least One Adverse Event |
2; 4; 6; 9; 5; 6 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an Adverse Event |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose |
NA; NA; NA; 155; 491; 1600 | — |
| PRIMARY AUC 0-24hr of Montelukast - Multiple Doses |
132; 403; 1576; 214; 576; 1850 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose |
NA; 5.10; 5.24; 18.5; 54.3; 224 | — |
| PRIMARY Cmax of Montelukast - Multiple Doses |
13.8; 60; 233; 23.4; 76; 242 | — |
| PRIMARY Time to Cmax (Tmax) of Montelukast - Single Dose |
NA; 2.5; 4.0; 2.4; 0.8; 0.5 | — |
| PRIMARY Tmax of Montelukast - Multiple Doses |
2.4; 0.5; 0.5; 0.7; 0.5; 0.6 | — |
| PRIMARY Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose |
NA; NA; NA; 5.7; 6.9; 5.7 | — |
| PRIMARY t1/2 of Montelukast - Multiple Doses |
8.2; 7.6; 7.7; NA; 8.1; 7.4 | — |
| PRIMARY AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses |
1.61; 1.44; 1.2; NA; 1.19; 1.26 | — |
| PRIMARY Cmax Accumulation Ratio of Montelukast - Multiple Doses |
1.73; 1.27; 1.03; NA; 1.03; 1.22 | — |
Summary
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00636207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.