Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-12 @ 10:05 AM
Study NCT ID:
NCT01926002
Status:
WITHDRAWN
Last Update Posted:
2015-07-16
First Post:
2013-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-Dose Study of MK-8351 in a Lung Allergen Challenge (MK-8351-003)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-15', 'studyFirstSubmitDate': '2013-08-16', 'studyFirstSubmitQcDate': '2013-08-16', 'lastUpdatePostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-3hr of FEV1 Percent Change From Baseline', 'timeFrame': '3 Hours'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'Up to 14 Days'}, {'measure': 'Number of Participants Discontinuing Study Treatment Due to AEs', 'timeFrame': 'Up to 72 Hours'}], 'secondaryOutcomes': [{'measure': 'AUC0-24h of MK-8351', 'timeFrame': 'Up to 24 Hours Post-Dose'}, {'measure': 'AUC0-last of MK-8351', 'timeFrame': 'Up to 72 Hours Post-Dose'}, {'measure': 'AUC0-∞ of MK-8351', 'timeFrame': 'Up to 72 Hours Post-Dose'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-8351', 'timeFrame': 'Up to 72 Hours Post-Dose'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of MK-8351', 'timeFrame': 'Up to 72 Hours Post-Dose'}, {'measure': 'Apparent Half-Life (t1/2) of MK-8351', 'timeFrame': 'Up to 72 Hours Post-Dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The primary hypothesis of the study is single doses of MK-8351 will reduce the baseline early asthmatic response (EAR) as assessed by area under the curve from 0-3 hours (AUC0-3hr) of forced expiratory volume (FEV1) when compared to placebo.', 'detailedDescription': 'This is a randomized, placebo-controlled, 4-period study. Eligible patients will undergo a single-blind phase in Period 1, followed by 3 periods during which they will receive low-dose MK-8351, high-dose MK-8351, or matching placebo as a single dose in a random sequence crossover study design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females of non-childbearing potential (at least 1 year post-menopausal, post-hysterectomy, post-oophorectomy, or with tubal ligation);\n* Males with a female partner of childbearing potential must agree to use a medically acceptable method of contraception during and up to 120 days after the last dose of study medication;\n* Body Mass Index (BMI) \\>=17 kg/m\\^2 and \\<=33 kg/m\\^2\n* Non-smoker and non-user of nicotine or nicotine-containing products for at least 6 months prior to enrollment;\n* History of allergen-induced asthma for at least 6 months prior to enrollment;\n* Able to perform reproducible pulmonary function testing;\n* Positive methacholine challenge test prior to receiving study medication;\n* Allergic response to house dust mite allergen or standardized cat pelt or hair allergen extract;\n* Ability to tolerate sputum induction and to produce adequate sputum.\n\nExclusion Criteria:\n\n* History of clinically significant disease or disorder;\n* History of malignancy;\n* History of significant multiple and/or severe allergies;\n* History of milk or lactose allergies or intolerance;\n* History of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;\n* Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies;\n* History of major surgery within 3 months prior to enrollment;\n* Participation in another investigational trial within 4 weeks of screening;\n* Lactating females;\n* Inability to refrain from, or anticipates the use of, any medication including herbal remedies during the trial period;\n* History of receiving anti-immunoglobulin E (IgE) or immunotherapy;\n* History of serious allergies to drug or a history of hypersensitivity to inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication;\n* History of hospitalization for asthma-related illness within 3 months of screening;\n* History of emergent care more than twice in the last 12 months for asthma-related illness;\n* History of life-threatening asthma;\n* Consumes \\>4 glasses of alcoholic beverage per day;\n* Consumes \\>6 servings of coffee, tea, cola, energy drinks or other caffeinated beverages per day;\n* History or or current use of illicit drugs within past 24 months.'}, 'identificationModule': {'nctId': 'NCT01926002', 'briefTitle': 'A Single-Dose Study of MK-8351 in a Lung Allergen Challenge (MK-8351-003)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter Randomized Clinical Trial to Study the Effects of Single Doses of MK-8351 on the Early Asthmatic Response to a Lung Allergen Challenge', 'orgStudyIdInfo': {'id': '8351-003'}, 'secondaryIdInfos': [{'id': 'MK-8351-003', 'type': 'OTHER', 'domain': 'Merck Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-Dose MK-8351', 'description': 'Low-dose MK-8351 administered as single inhaled dose.', 'interventionNames': ['Drug: Low-Dose MK-8351']}, {'type': 'EXPERIMENTAL', 'label': 'High-Dose MK-8351', 'description': 'High-dose MK-8351 administered as a single inhaled dose.', 'interventionNames': ['Drug: High-Dose MK-8351']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to MK-8351', 'description': 'Matching placebo to low-dose or high-dose MK-8351 administered as a single inhaled dose.', 'interventionNames': ['Drug: Placebo to MK-8351']}], 'interventions': [{'name': 'Low-Dose MK-8351', 'type': 'DRUG', 'description': 'Single administration of low-dose MK-8351.', 'armGroupLabels': ['Low-Dose MK-8351']}, {'name': 'High-Dose MK-8351', 'type': 'DRUG', 'description': 'High-Dose MK-8351 administered as a single inhaled dose.', 'armGroupLabels': ['High-Dose MK-8351']}, {'name': 'Placebo to MK-8351', 'type': 'DRUG', 'description': 'Single-Dose Matching placebo to high-dose or low-dose MK-8351.', 'armGroupLabels': ['Placebo to MK-8351']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}