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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Drug: Placebo for MK-1029

Drug: MK-1029

Study type

Interventional

Funder types

Industry

Identifiers

NCT01370317

1029-006

MK-1029-006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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