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

ClinicalTrials.gov Identifier:

NCT01343407

First received: April 26, 2011

Last updated: February 9, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 26, 2011
Last Updated Date	February 9, 2012
Start Date ^ICMJE	April 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2012)	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) ]
Original Primary Outcome Measures ^ICMJE (submitted: April 26, 2011)	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 ]
Change History	Complete list of historical versions of study NCT01343407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 9, 2012)	Percentage inhibition of eosinophil CD11b expression [ Time Frame: Baseline (Day 1 predose) and 24 hours after dosing on Day 5 ]
Original Secondary Outcome Measures ^ICMJE (submitted: April 26, 2011)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Two-part Study of the Effects of MK-1029 in Allergen-challenged Asthmatics (MK-1029-003 AM1)
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Asthma
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	16
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01343407
Other Study ID Numbers ^ICMJE	MK-1029-003, 2010-022391-31
Has Data Monitoring Committee	Not Provided
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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