A Two-part Study of the Effects of MK-1029 in Allergen-challenged Asthmatics (MK-1029-003 AM1)
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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 |
- 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) ]
- 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 |
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
More Information
No publications provided
| Responsible Party: | Merck |
| 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 May 19, 2013