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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 (MK-0476-380 AM3)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00636207
First received: March 3, 2008
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Montelukast
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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.


Enrollment: 46
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Montelukast
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
Other Names:
  • Montelukast Sodium
  • MK-0476
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.
Drug: Montelukast
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
Other Names:
  • Montelukast Sodium
  • MK-0476
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.
Drug: Montelukast
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
Other Names:
  • Montelukast Sodium
  • MK-0476
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.
Drug: Montelukast
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
Other Names:
  • Montelukast Sodium
  • MK-0476
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.
Drug: Montelukast
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
Other Names:
  • Montelukast Sodium
  • MK-0476
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.
Drug: Placebo
Placebo dry powder inhaler

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636207

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00636207     History of Changes
Other Study ID Numbers: 0476-380, 2008_516
Study First Received: March 3, 2008
Results First Received: December 20, 2012
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014