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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01370317
First received: June 8, 2011
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Asthma
Drug: MK-1029
Drug: Placebo for MK-1029
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the concentration-time curve from time 0 to 6 hours (AUC0-6hr) [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: No ]
  • Time to maximum concentration (Tmax) [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370317

Locations
United States, California
Call for Information
Costa Mesa, California, United States, 92626
Call for Information
Rolling Hills Estates, California, United States, 90274
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01370317     History of Changes
Other Study ID Numbers: MK-1029-006
Study First Received: June 8, 2011
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014