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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636207
• Other study ID #: 0476-380
• Secondary ID: 2008_516
• Status: Completed
• Phase: Phase 1
• Start date: August 2007
• Est. completion date: October 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Montelukast
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
• Placebo
Placebo dry powder inhaler

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced At Least One Adverse Event		Up to 14 days after last dose of study drug
Primary	Number of Participants Who Discontinued Study Drug Due to an Adverse Event		Up to 7 days after last dose of study drug
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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