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)

NCT00636207 | Completed Phase 1 Results

• 2 other identifiers: 0476-3802008_516
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (12)

• 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

  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.

  Up to 24 hours postdose

• AUC 0-24hr of Montelukast - Multiple Doses

  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.

  Up to 24 hours postdose

• Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose

  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.

  Up to 24 hours postdose

• Cmax of Montelukast - Multiple Doses

  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.

  Up to 24 hours postdose

• Time to Cmax (Tmax) of Montelukast - Single Dose

  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.

  Up to 24 hours postdose

• Tmax of Montelukast - Multiple Doses

  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.

  Up to 24 hours postdose

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

  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.

  Up to 24 hours postdose

• t1/2 of Montelukast - Multiple Doses

  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.

  Up to 24 hours postdose

• AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses

  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.

  up to 10 days after first dose of study drug

• Cmax Accumulation Ratio of Montelukast - Multiple Doses

  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.

  up to 10 days after first dose of study drug

Study Arms (6)

Montelukast 0.1 mg

EXPERIMENTAL

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 0.3 mg

EXPERIMENTAL

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 1 mg

EXPERIMENTAL

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 3 mg

EXPERIMENTAL

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 10 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Montelukast DRUG

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

Also known as: Montelukast Sodium, MK-0476

Montelukast 0.1 mg; Montelukast 0.3 mg; Montelukast 1 mg; Montelukast 10 mg; Montelukast 3 mg

Placebo DRUG

Placebo dry powder inhaler

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Vice President,Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 14, 2008
• Study Start: August 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 9, 2024
• Results First Posted: January 28, 2013

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share