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| ID | Type | Description | Link |
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| 2008_516 | Other Identifier | Merck Registration ID |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast 0.1 mg | Experimental | Participants receive Montelukast inhalation powder, 0.1 mg.
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| Montelukast 0.3 mg | Experimental | Participants receive Montelukast inhalation powder, 0.3 mg.
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| Montelukast 1 mg | Experimental | Participants receive Montelukast inhalation powder, 1 mg.
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| Montelukast 3 mg | Experimental | Participants receive Montelukast inhalation powder, 3 mg.
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| Montelukast 10 mg | Experimental | Participants receive Montelukast inhalation powder, 10 mg.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Participants were recruited from 3 study sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part I - Montelukast | Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg). Each dose was separated by at least a 3-day washout period. |
| FG001 | Part I - Montelukast and Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Placebo Comparator | Participants receive Placebo to Montelukast inhalation powder.
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| Placebo | Drug | Placebo dry powder inhaler |
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| 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 |
Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period. |
| FG002 | Part II - Montelukast | Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period. |
| FG003 | Part II - Placebo | Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive QD doses of inhaled Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period. |
| FG004 | Part III - Montelukast | Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period. |
| FG005 | Part III - Montelukast and Placebo | Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period. |
| FG006 | Part III - Placebo | Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part I | Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period. |
| BG001 | Part II | Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) or Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period. |
| BG002 | Part III | Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Experienced At Least One Adverse Event | Safety Population: All participants who received at least one dose of study drug | Posted | Number | participants | Up to 14 days after last dose of study drug |
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| Primary | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Safety Population: All participants who received at least one dose of study drug | Posted | Number | participants | Up to 7 days after last dose of study drug |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Mean | Standard Deviation | ng/mL*hr | Up to 24 hours postdose |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Mean | Standard Deviation | ng/mL*hr | Up to 24 hours postdose |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Mean | Standard Deviation | ng/mL | Up to 24 hours postdose |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Mean | Standard Deviation | ng/mL | Up to 24 hours postdose |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Median | Full Range | hours | Up to 24 hours postdose |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Median | Full Range | hours | Up to 24 hours postdose |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Mean | Standard Deviation | hours | Up to 24 hours postdose |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Mean | Standard Deviation | hours | Up to 24 hours postdose |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Number | ratio | up to 10 days after first dose of study drug |
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| 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. | Per Protocol Population: All participants who complied with the protocol | Posted | Number | ratio | up to 10 days after first dose of study drug |
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Up to 14 days after last dose of study drug
Safety Population: All participants who received at least one dose of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Montelukast 0.1 mg | Participants receiving Montelukast 0.1 mg inhalation powder | 0 | 7 | 2 | 7 | ||
| EG001 | Montelukast 0.3 mg | Participants receiving Montelukast 0.3 mg inhalation powder | 0 | 7 | 4 | 7 | ||
| EG002 | Montelukast 1 mg | Participants receiving Montelukast 1 mg inhalation powder | 0 | 12 | 6 | 12 | ||
| EG003 | Montelukast 3 mg | Participants receiving Montelukast 3 mg inhalation powder | 0 | 18 | 9 | 18 | ||
| EG004 | Montelukast 10 mg | Participants receiving Montelukast 10 mg inhalation powder | 0 | 19 | 5 | 19 | ||
| EG005 | Placebo | Participants receiving Placebo inhalation powder | 0 | 18 | 6 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Paraesthesia Oral | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Herpes Simplex | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Vaginal Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Blood Bilirubin Increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Periorbital Oedema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President,Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
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| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Male |
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| OG005 |
| Placebo |
Participants receiving Placebo inhalation powder |
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Participants receiving Montelukast 3 mg inhalation powder |
| OG005 | Montelukast 10 mg | Participants receiving Montelukast 10 mg inhalation powder |
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Participants receiving Montelukast 3 mg inhalation powder
| OG005 | Montelukast 10 mg | Participants receiving Montelukast 10 mg inhalation powder |
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Participants receiving Montelukast 3 mg inhalation powder
| OG005 | Montelukast 10 mg | Participants receiving Montelukast 10 mg inhalation powder |
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Participants receiving Montelukast 3 mg inhalation powder
| OG005 | Montelukast 10 mg | Participants receiving Montelukast 10 mg inhalation powder |
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