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)

Overview[ - collapse ][ - ]

Purpose A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.
ConditionAsthma
InterventionDrug: Montelukast
Drug: Placebo
PhasePhase 1
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT00636207
First ReceivedMarch 3, 2008
Last UpdatedNovember 22, 2013
Last verifiedNovember 2013

Tracking Information[ + expand ][ + ]

First Received DateMarch 3, 2008
Last Updated DateNovember 22, 2013
Start DateAugust 2007
Estimated Primary Completion DateOctober 2008
Current Primary Outcome Measures
  • Number of Participants Who Experienced At Least One Adverse Event [Time Frame: Up to 14 days after last dose of study drug] [Designated as safety issue: Yes]
  • Number of Participants Who Discontinued Study Drug Due to an Adverse Event [Time Frame: Up to 7 days after last dose of study drug] [Designated as safety issue: Yes]
  • Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose [Time Frame: Up to 24 hours postdose] [Designated as safety issue: No]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.
  • AUC 0-24hr of Montelukast - Multiple Doses [Time Frame: Up to 24 hours postdose] [Designated as safety issue: No]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.
  • Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose [Time Frame: Up to 24 hours postdose] [Designated as safety issue: No]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.
  • Cmax of Montelukast - Multiple Doses [Time Frame: Up to 24 hours postdose] [Designated as safety issue: No]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 [Time Frame: Up to 24 hours postdose] [Designated as safety issue: No]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.
  • Tmax of Montelukast - Multiple Doses [Time Frame: Up to 24 hours postdose] [Designated as safety issue: No]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.
  • Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose [Time Frame: Up to 24 hours postdose] [Designated as safety issue: No]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.
  • t1/2 of Montelukast - Multiple Doses [Time Frame: Up to 24 hours postdose] [Designated as safety issue: No]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 Accumulation Ratio of Montelukast - Multiple Doses [Time Frame: up to 10 days after first dose of study drug] [Designated as safety issue: No]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.
  • Cmax Accumulation Ratio of Montelukast - Multiple Doses [Time Frame: up to 10 days after first dose of study drug] [Designated as safety issue: No]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.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleA 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)
Official TitleA 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
Brief Summary
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast
(MK-0476) in participants with mild or moderate asthma.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionAsthma
InterventionDrug: Montelukast
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
Other Names:
  • Montelukast Sodium
  • MK-0476
Drug: Placebo
Placebo dry powder inhaler
Study Arm (s)
  • Experimental: Montelukast 0.1 mg
    Participants receive Montelukast inhalation powder, 0.1 mg.
    Part I: Administered as a single dose followed by at least a 3-day washout period.
  • Experimental: Montelukast 0.3 mg
    Participants receive Montelukast inhalation powder, 0.3 mg.
    Part I: Administered as a single dose followed by at least a 3-day washout period.
  • Experimental: Montelukast 1 mg
    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.
  • Experimental: Montelukast 3 mg
    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.
  • Experimental: Montelukast 10 mg
    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.
  • Placebo Comparator: 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment46
Estimated Completion DateOctober 2008
Estimated Primary Completion DateSeptember 2008
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00636207
Other Study ID Numbers0476-380
Has Data Monitoring CommitteeNot Provided
Information Provided ByMerck Sharp & Dohme Corp.
Study SponsorMerck Sharp & Dohme Corp.
CollaboratorsNot Provided
Investigators Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification DateNovember 2013