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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01370317
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: MK-1029 Drug: Placebo for MK-1029 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: MK-1029 Drug: MK-1029
Five (5) X 100 mg capsules, orally, once daily for 28 days

Placebo Comparator: Placebo Drug: Placebo for MK-1029
Five (5) X 100 mg capsules, orally, once daily for 28 days

Primary Outcome Measures :
  1. Number of Participants Who Experience Clinical and Laboratory Adverse Experiences [ Time Frame: Day -1 up to 14 days after administration of last dose of study drug ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve from time 0 to 6 hours (AUC0-6hr) [ Time Frame: Day 1 and Day 28 ]
  2. Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and Day 28 ]
  3. Time to maximum concentration (Tmax) [ Time Frame: Day 1 and Day 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01370317

United States, California
Call for Information
Costa Mesa, California, United States, 92626
Call for Information
Rolling Hills Estates, California, United States, 90274
Merck Sharp & Dohme
North Ryde, Australia
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd.,
Wellington, New Zealand
South Africa
MSD (Pty) LTD South Africa
Midrand, South Africa
Sponsors and Collaborators
Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01370317     History of Changes
Other Study ID Numbers: 1029-006
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases