Clinical trial NCT01370317: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
Official title: Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants Who Experienced One or More Adverse Events
timeFrame: Up to 42 days after initial dose of study treatment
measure: Number of Participants Who Discontinued Study Treatment Due to An Adverse Event
timeFrame: Up to 28 days after initial dose of study treatment
Secondary outcomes:
measure: Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029
timeFrame: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
measure: Maximum Plasma Concentration (Cmax) of MK-1029
timeFrame: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
measure: Time to Maximum Plasma Concentration (Tmax) of MK-1029
timeFrame: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Call for Information
state: California
city: Rolling Hills Estates
country: United States
facility: Call for Information
state: California
city: North Ryde
country: Australia
facility: Merck Sharp & Dohme
city: Wellington
country: New Zealand
facility: Merck Sharp & Dohme (New Zealand) Ltd.,
city: Midrand
country: South Africa
facility: MSD (Pty) LTD South Africa
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: