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

• Status: Completed
• Trial end date: 2011-12-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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