A Two-part Study of the Effects of MK-1029 in Allergen-challenged Asthmatics (MK-1029-003 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01343407
First received: April 26, 2011
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

Part I of the study will verify optimal execution of the procedures and acquisition of satisfactory samples that will be utilized in the main study (Part II); no drug will be administered. Part II will assess the effect of multiple doses of MK-1029 on the changes in allergen-induced sputum eosinophils and changes in allergen-induced late asthmatic response (LAR) when compared to placebo.


Condition Intervention Phase
Asthma
Drug: MK-1029 10 mg
Drug: MK-1029 100 mg
Drug: Placebo for MK-1029 10 mg
Drug: Placebo for MK-1029 100 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Two-Part, Multicenter, Randomized, Clinical Trial to Study the Effects of Multiple Doses of MK-1029 on the Late Asthmatic Response to Lung Allergen Challenge in Asthmatics

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in the percentage of eosinophils in induced sputum [ Time Frame: Baseline (Day -1) and 8 hours after allergen challenge (Day 5) ]
  • Forced expiratory volume at 1 second (FEV1) area under the curve from 3 to 8 hours (AUC[3-8hr]) [ Time Frame: Hour 3 to Hour 8 after allergen challenge (Day 5) ]

Secondary Outcome Measures:
  • Percentage inhibition of eosinophil CD11b expression [ Time Frame: Baseline (Day 1 predose) and 24 hours after dosing on Day 5 ]

Enrollment: 16
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 60 mg MK-1029
Part II - Participants will receive 60 mg MK-1029 in one out of four study periods
Drug: MK-1029 10 mg
Six capsules once daily for 5 days
Drug: Placebo for MK-1029 100 mg
Five capsules once daily for 5 days
Experimental: 500 mg MK-1029
Part II - Participants will receive 500 mg MK-1029 in one out of four study periods
Drug: MK-1029 100 mg
Five capsules once daily for 5 days
Drug: Placebo for MK-1029 10 mg
Six capsules once daily for 5 days
Placebo Comparator: Placebo
Part II - Participants will receive placebo to MK-1029 in two out of four study periods
Drug: Placebo for MK-1029 10 mg
Six capsules once daily for 5 days
Drug: Placebo for MK-1029 100 mg
Five capsules once daily for 5 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

Parts I and II

  • Is male or a female of non-childbearing potential
  • Has a history of allergen-induced asthma for at least 6 months
  • Is judged to be in good health (other than asthma)
  • Is able to perform reproducible pulmonary function testing
  • Has a positive methacholine challenge test on Day -1
  • Has an allergic response to house dust mite allergen as defined by positive skin prick test
  • Is a nonsmoker and/ or has not used nicotine or nicotine-containing products for at least 12 months
  • Has body mass index (BMI) ≥17 kg/m^2, but ≤33 kg/m^2

Part II only

  • Must demonstrate a dual airway response to an allergen challenge in Period 1, decrease in FEV1 of at least 20% 0 to 2 hours after allergen challenge for early asthmatic response (EAR) and a positive late asthmatic response (LAR) to an inhaled allergen challenge as defined by a bronchoconstrictive response of at least 15% reduction in FEV1 3 to 8 hours after allergen challenge
  • Can tolerate sputum induction and produce adequate sputum

Exclusion Criteria:

Parts I and II

  • Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses additional risk to the participant
  • Has recent (4 weeks) or ongoing upper or lower respiratory tract infection
  • Is unable to refrain from or anticipates the use of any medication other than the ones permitted in this study
  • Has taken oral, intramuscular, intra-articular, high-potency topical or orally inhaled corticosteroids within 8 weeks
  • Has taken the following medications outside the washout margins: nasal corticosteroids and anti-leukotrienes within 3 weeks; inhaled long-acting β2-agonists, long-acting antihistamines (e.g., loratadine, sustained-release agents), intra-nasal anticholinergics over-the-counter decongestants within 1 week; short-acting oral decongestants, short-acting antihistamines (e.g., chlorpheniramine) within 48 hours
  • Consumes excessive amounts of alcohol or caffeinated beverages
  • Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 3 months
  • Has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Is a nursing mother
  • Has a history of receiving anti-immunoglobulin E (IgE) or immunotherapy
  • Has a history of serious allergies to drugs or a history of hypersensitivity to mometasone furoate or any of its inactive ingredients such as lactose, or inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication

Part II only

- Has a decline in FEV1 of 70% or greater from the post allergen diluent baseline and/or FEV1 <1.0L or has symptomatic drop in FEV1 associated with shortness of breath unresolved with bronchodilators within a reasonable timeframe (60 minutes) after the allergen challenge study in Period 1

  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: NCT01343407

Locations
United Kingdom
Merck Sharp & Dohme Ltd.
Hoddesdon, Hertfordshire, United Kingdom, EN11 9BU
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01343407     History of Changes
Other Study ID Numbers: MK-1029-003, 2010-022391-31
Study First Received: April 26, 2011
Last Updated: February 9, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 July 28, 2014