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

Completed · Phase 1 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01370317

Run by

Merck Sharp & Dohme LLC

People needed

27

Starts

2011-06-01

Expected to finish

2011-12-27

Last updated by the study team

2019-01-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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