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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014