Phase 1
N=27
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01370317 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants Who Experienced One or More Adverse Events — 9; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MK-1029 (Drug); Placebo for MK-1029 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced One or More Adverse Events |
9; 3 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to An Adverse Event |
0; 0 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029 |
745; 505 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of MK-1029 |
295; 167 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of MK-1029 |
2.00; 3.00 | — |
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
Data sourced from ClinicalTrials.gov (NCT01370317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.