Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma

Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose treatment with MK-1029 in adults with mild to moderate persistent asthma.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: MK-1029; Drug: Placebo for MK-1029

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • North Ryde, Australia
    • Merck Sharp & Dohme
• New Zealand
  • Wellington, New Zealand
    • Merck Sharp & Dohme (New Zealand) Ltd.,
• South Africa
  • Midrand, South Africa
    • MSD (Pty) LTD South Africa
• United States
  • California
    • Costa Mesa, California, United States, 92626
      • Call For Information
    • Rolling Hills Estates, California, United States, 90274
      • Call For Information

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• If female, must be of non-childbearing potential
• Have a history of mild to moderate asthma for at least 6 months
• Other than asthma, in general good health
• Able to perform reproducible pulmonary function testing
• Is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 12 months
• Have body mass index (BMI) ≥17 kg/m^2, but ≤35 kg/m^2

Exclusion Criteria:

• Demonstrate a decrease in absolute forced expiratory volume in 1 second (FEV1) of >20% from the Screening Visit to the Baseline Visit
• Experience a decrease in AM or PM peak expiratory flow (PEF) below the Stability Limit on any 2 consecutive days prior to the Baseline Visit
• Require the use of >8 inhalations per day of short-acting beta2-agonist metered dose inhaler (MDI) or >2 nebulized treatments per day of 2.5 mg albuterol, on any 2 consecutive days from the Screening Visit up to the Baseline Visit
• Experience an exacerbation defined as a clinical deterioration of asthma, as judged by the clinical investigator, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded medication (other than short-acting beta agonists [SABA]) at any time from the Screening Visit up to the Baseline Visit
• Have been hospitalized for treatment of asthma or required oral corticosteroids for treatment of asthma within the past 6 months, or has ever required ventilator support for respiratory failure secondary to asthma
• Require the chronic use of high-dose inhaled corticosteroids
• Have been diagnosed with chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease, other than asthma
• Have a history of any illness that might confound the results of the study or poses additional risk to the participant
• Have had recent (within 4 weeks of first dose) or ongoing upper or lower respiratory tract infection
• Is nursing
• Have a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo for MK-1029; Five (5) X 100 mg capsules, orally, once daily for 28 days
Experimental: MK-1029	Drug: MK-1029; Five (5) X 100 mg capsules, orally, once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced One or More Adverse Events	An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	Up to 42 days after initial dose of study treatment
Number of Participants Who Discontinued Study Treatment Due to An Adverse Event	An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	Up to 28 days after initial dose of study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029	Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.	Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Maximum Plasma Concentration (Cmax) of MK-1029	Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.	Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Time to Maximum Plasma Concentration (Tmax) of MK-1029	Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Tmax of MK-1026.	Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): December 27, 2011
• Study Completion (Actual): December 27, 2011

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 1029-006; MK-1029-006 (OTHER: Merck Protocol Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf