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Completed

NCT Number: NCT00636207

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)

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg

Other names: Montelukast Sodium, MK-0476

Placebo

Drug

Placebo dry powder inhaler

Primary outcomes

  1. Number of Participants Who Experienced At Least One Adverse Event

    Time frame: Up to 14 days after last dose of study drug

  2. Number of Participants Who Discontinued Study Drug Due to an Adverse Event

    Time frame: Up to 7 days after last dose of study drug

  3. Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose

    Time frame: 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.

  4. AUC 0-24hr of Montelukast - Multiple Doses

    Time frame: 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.

  5. Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose

    Time frame: 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.

  6. Cmax of Montelukast - Multiple Doses

    Time frame: 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.

  7. Time to Cmax (Tmax) of Montelukast - Single Dose

    Time frame: 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.

  8. Tmax of Montelukast - Multiple Doses

    Time frame: 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.

  9. Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose

    Time frame: 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.

  10. t1/2 of Montelukast - Multiple Doses

    Time frame: 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.

  11. AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses

    Time frame: 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.

  12. Cmax Accumulation Ratio of Montelukast - Multiple Doses

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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