A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012)

NCT ID: NCT01656395

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-23
• Study Completion Date: 2014-07-08

Brief Summary

This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and safety of MK-1029 compared with placebo using measures of lung function (forced expiratory volume in 1 second [FEV1]). The primary objectives are (1) To demonstrate that MK-1029, compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of the 12-week active-treatment period; and (2) To determine the dose-related safety and tolerability of MK-1029 as monotherapy and as concomitant dosing with montelukast over 12 weeks. The primary hypothesis is: MK-1029 is superior to placebo in a dose-related fashion in the average change from baseline in FEV1 over the last 6 weeks of the 12-week active-treatment period.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-1029 10 mg

Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks

Group Type: EXPERIMENTAL

MK-1029

Intervention Type: DRUG

MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.

MK-1029 30 mg

Participants receive MK-1029 30 mg tablets QD for 12 weeks

Group Type: EXPERIMENTAL

MK-1029

Intervention Type: DRUG

MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.

MK-1029 60 mg

Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks

Group Type: EXPERIMENTAL

MK-1029

Intervention Type: DRUG

MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.

MK-1029 150 mg

Participants will receive MK-1029 150 mg tablets QD for 12 weeks

Group Type: EXPERIMENTAL

MK-1029

Intervention Type: DRUG

MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.

Montelukast 10 mg

Participants will receive Montelukast 10 mg tablets QD for 12 weeks

Group Type: ACTIVE_COMPARATOR

Montelukast 10 mg

Intervention Type: DRUG

Parts I-II: Participants will receive Montelukast 10 mg tablets QD

Placebo

Participants will receive Placebo tablets QD for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Parts I-II: Participants will receive Placebo tablets QD

MK-1029 1 mg or 3 mg

Participants will receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD.

Group Type: EXPERIMENTAL

MK-1029

Intervention Type: DRUG

MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.

Montelukast 10 mg + MK-1029

Participants will receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD

Group Type: EXPERIMENTAL

Montelukast 10 mg

Intervention Type: DRUG

Parts I-II: Participants will receive Montelukast 10 mg tablets QD

Interventions

MK-1029

MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.

Intervention Type: DRUG

Montelukast 10 mg

Parts I-II: Participants will receive Montelukast 10 mg tablets QD

Intervention Type: DRUG

Placebo

Parts I-II: Participants will receive Placebo tablets QD

Intervention Type: DRUG

Other Intervention Names

SINGULAIR®

Eligibility Criteria

Inclusion Criteria

• not pregnant or breastfeeding, and not planning to become pregnant during the study
• history of symptoms of persistent asthma for at least one year
• current use of acceptable asthma treatments and willingness to taper or discontinue these treatments; acceptable asthma treatments:

• use of inhaled SABAs (e.g., albuterol/salbutamol) only "as-needed" with no use of asthma controller medications; OR
• use of stable doses of low- or medium-dose inhaled corticosteroids (ICS), alone, or in combination with either a long-acting beta-agonist (LABA) or other asthma controller medications (including leukotriene receptor antagonists) and can tolerate tapering or discontinuation
• no history of smoking OR no smoking within <1 year with a smoking history of ≤10 pack-years
• ability to maintain a constant day/night, awake/sleep cycle
• agreement to not change habitual consumption of beverages or food containing caffeine throughout the study
• Body Mass Index (BMI) of 15 to 40 kg/m^2

Exclusion Criteria

• myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within past ≤3 months
• hospitalization within past ≤4 weeks
• major surgical procedure within past ≤4 weeks
• participation in a clinical study involving an investigational drug within past ≤4 weeks
• current regular use or recent (within past ≤5 years) past abuse of alcohol (>14 drinks/week) or illicit drugs
• donation of a unit of blood within past ≤2 weeks or intention to donate a unit of blood during the study
• evidence of another clinically significant, active pulmonary disorder such as chronic obstructive pulmonary disease (COPD)
• emergency room treatment for asthma within past ≤4 weeks or hospitalization for asthma within past ≤8 weeks
• respiratory tract infection requiring antibiotic treatment within past ≤8 weeks
• evidence of active, clinically significant sinus disease within past ≤1 week
• history of a clinically significant psychiatric disorder, other than stable depression, within past ≤12 weeks
• history of HIV
• hypersensitivity or intolerance to inhaled beta-agonists, leukotriene antagonists, leukotriene synthesis inhibitors, or any of their ingredients, including lactose and galactose
• clinically unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems
• current cancer or history (within past ≤5 years) of cancer (except for successfully treated basal and squamous cell carcinomas of the skin); if cancer-free for >5 years, study participation may be allowed
• evidence of uncontrolled hypertension

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2012-000643-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

132230

Identifier Type: REGISTRY

Identifier Source: secondary_id

1029-012

Identifier Type: -

Identifier Source: org_study_id