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
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 April 23, 2014