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

April 26, 2011
February 9, 2012
April 2011
January 2012   (final data collection date for primary outcome measure)
  • 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) ]
  • Change from baseline in the percentage of eosinophils in induced sputum [ Time Frame: Baseline (Day -1) and 8 hours after allergen challenge (Day 5) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01343407 on ClinicalTrials.gov Archive Site
Percentage inhibition of eosinophil CD11b expression [ Time Frame: Baseline (Day 1 predose) and 24 hours after dosing on Day 5 ]
Percentage inhibition of eosinophil CD11b expression [ Time Frame: Baseline (Day 1 predose) and 24 hours after dosing on Day 5 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Two-part Study of the Effects of MK-1029 in Allergen-challenged Asthmatics (MK-1029-003 AM1)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: MK-1029 10 mg
    Six capsules once daily for 5 days
  • 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
  • Drug: Placebo for MK-1029 100 mg
    Five capsules once daily for 5 days
  • Experimental: 60 mg MK-1029
    Part II - Participants will receive 60 mg MK-1029 in one out of four study periods
    Interventions:
    • Drug: MK-1029 10 mg
    • Drug: Placebo for MK-1029 100 mg
  • Experimental: 500 mg MK-1029
    Part II - Participants will receive 500 mg MK-1029 in one out of four study periods
    Interventions:
    • Drug: MK-1029 100 mg
    • Drug: Placebo for MK-1029 10 mg
  • Placebo Comparator: Placebo
    Part II - Participants will receive placebo to MK-1029 in two out of four study periods
    Interventions:
    • Drug: Placebo for MK-1029 10 mg
    • Drug: Placebo for MK-1029 100 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2012
January 2012   (final data collection date for primary outcome measure)

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

Both
18 Years to 55 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01343407
MK-1029-003, 2010-022391-31
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP