Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 10:20 AM
Study NCT ID:
NCT01140061
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2010-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42', 'description': 'The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.', 'eventGroups': [{'id': 'EG000', 'title': 'Panel A - MK-0873 5.1 mg', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.', 'otherNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Panel B - MK-0873 25 mg', 'description': 'In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Panel C - MK-0873 100 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Panel D - MK-0873 200 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Panel E and Extension - MK-0873 200 mg', 'description': 'In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.', 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo - Pooled', 'description': 'In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Burning Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection-site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With an Adverse Event of Erythema in Part I of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A - MK-0873 5.1 mg', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.'}, {'id': 'OG001', 'title': 'Panel A - Placebo', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 22 in Part 1', 'description': 'Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least one dose of study medication in Part I of the study.'}, {'type': 'PRIMARY', 'title': 'Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A - MK-0873 5.1 mg', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.'}, {'id': 'OG001', 'title': 'Panel B - MK-0873 25 mg', 'description': 'In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.'}, {'id': 'OG002', 'title': 'Panel C - MK-0873 100 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.'}, {'id': 'OG003', 'title': 'Panel D - MK-0873 200 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.'}, {'id': 'OG004', 'title': 'Panel E and Extension - MK-0873 200 mg', 'description': 'In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The value was below the lower limit of quantification.', 'groupId': 'OG000'}, {'value': '9.10', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '5.22', 'spread': '2.97', 'groupId': 'OG002'}, {'value': '12.0', 'spread': '3.41', 'groupId': 'OG003'}, {'value': '9.76', 'spread': '6.42', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 11', 'description': 'Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received MK-0873 and for whom blood samples were collected and evaluable to determine Cmax.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A - MK-0873 5.1 mg', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.'}, {'id': 'OG001', 'title': 'Panel B - MK-0873 25 mg', 'description': 'In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.'}, {'id': 'OG002', 'title': 'Panel C - MK-0873 100 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.'}, {'id': 'OG003', 'title': 'Panel D - MK-0873 200 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.'}, {'id': 'OG004', 'title': 'Panel E and Extension - MK-0873 200 mg', 'description': 'In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.'}, {'id': 'OG005', 'title': 'Placebo - Pooled', 'description': 'In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after last dose of study drug (up to Day 42)', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least one dose of study medication for whom safety data were available.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Medication Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A - MK-0873 5.1 mg', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.'}, {'id': 'OG001', 'title': 'Panel B - MK-0873 25 mg', 'description': 'In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.'}, {'id': 'OG002', 'title': 'Panel C - MK-0873 100 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.'}, {'id': 'OG003', 'title': 'Panel D - MK-0873 200 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.'}, {'id': 'OG004', 'title': 'Panel E and Extension - MK-0873 200 mg', 'description': 'In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.'}, {'id': 'OG005', 'title': 'Placebo - Pooled', 'description': 'In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all enrolled participants who received at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panel A - MK-0873 5.1 mg', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.'}, {'id': 'FG001', 'title': 'Panel A - Placebo', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.'}, {'id': 'FG002', 'title': 'Panel B - MK-0873 25 mg', 'description': 'In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.'}, {'id': 'FG003', 'title': 'Panel B - Placebo', 'description': 'In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.'}, {'id': 'FG004', 'title': 'Panel C - MK-0873 100 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.'}, {'id': 'FG005', 'title': 'Panel C - Placebo', 'description': 'In Part II, healthy participants received skin application of placebo cream once daily for 10 days.'}, {'id': 'FG006', 'title': 'Panel D - MK-0873 200 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.'}, {'id': 'FG007', 'title': 'Panel D - Placebo', 'description': 'In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.'}, {'id': 'FG008', 'title': 'Panel E and Extension - MK-0873 200 mg', 'description': 'In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.'}, {'id': 'FG009', 'title': 'Panel E and Extension - Placebo', 'description': 'In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.'}], 'periods': [{'title': 'Part I', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Includes 1 replacement participant', 'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Part II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Part III', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'comment': 'Includes 1 replacement participant', 'groupId': 'FG009', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Laboratory Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '42', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Panel A - MK-0873 5.1 mg', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.'}, {'id': 'BG001', 'title': 'Panel A - Placebo', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days'}, {'id': 'BG002', 'title': 'Panel B - MK-0873 25 mg', 'description': 'In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.'}, {'id': 'BG003', 'title': 'Panel B - Placebo', 'description': 'In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.'}, {'id': 'BG004', 'title': 'Panel C - MK-0873 100 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.'}, {'id': 'BG005', 'title': 'Panel C - Placebo', 'description': 'In Part II, healthy participants received skin application of placebo cream once daily for 10 days.'}, {'id': 'BG006', 'title': 'Panel D - MK-0873 200 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days'}, {'id': 'BG007', 'title': 'Panel D - Placebo', 'description': 'In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.'}, {'id': 'BG008', 'title': 'Panel E and Extension - MK-0873 200 mg', 'description': 'In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.'}, {'id': 'BG009', 'title': 'Panel E and Extension - Placebo', 'description': 'In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.71', 'spread': '12.19', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '53'}, {'value': '30.50', 'spread': '17.68', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '43'}, {'value': '40.00', 'spread': '11.78', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '60'}, {'value': '45.50', 'spread': '14.85', 'groupId': 'BG003', 'lowerLimit': '35', 'upperLimit': '56'}, {'value': '45.67', 'spread': '12.79', 'groupId': 'BG004', 'lowerLimit': '28', 'upperLimit': '62'}, {'value': '34.00', 'spread': '7.07', 'groupId': 'BG005', 'lowerLimit': '29', 'upperLimit': '39'}, {'value': '30.33', 'spread': '6.77', 'groupId': 'BG006', 'lowerLimit': '21', 'upperLimit': '38'}, {'value': '35.50', 'spread': '2.12', 'groupId': 'BG007', 'lowerLimit': '34', 'upperLimit': '37'}, {'value': '42.86', 'spread': '11.33', 'groupId': 'BG008', 'lowerLimit': '23', 'upperLimit': '54'}, {'value': '40.00', 'spread': '15.56', 'groupId': 'BG009', 'lowerLimit': '29', 'upperLimit': '51'}, {'value': '39.67', 'spread': '11.49', 'groupId': 'BG010', 'lowerLimit': '18', 'upperLimit': '62'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '22', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '20', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2011-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2010-06-07', 'resultsFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-11', 'studyFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With an Adverse Event of Erythema in Part I of the Study', 'timeFrame': 'Up to Day 22 in Part 1', 'description': 'Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}, {'measure': 'Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days', 'timeFrame': 'Day 11', 'description': 'Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis'}, {'measure': 'Number of Participants With an Adverse Event', 'timeFrame': 'Up to 14 days after last dose of study drug (up to Day 42)', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}, {'measure': 'Number of Participants Who Discontinued Study Medication Due to an Adverse Event', 'timeFrame': 'Up to Day 28', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0873-020&kw=0873-020&tab=access', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the incidence of erythema and other local cutaneous irritation after administration of MK-0873 by patch or cream formulation in healthy participants and participants with mild psoriasis. Part I and Part II in healthy participants will be initiated prior to Part III in psoriasis participants. The primary hypotheses of the study are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with psoriasis and 2) that the maximum plasma concentration of MK-0873 is \\<20 nM in healthy participants and participants with psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart I, II and III:\n\n* Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control;\n* In good general health;\n* Nonsmoker;\n\nPart III only:\n\n* Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total body surface area;\n\nExclusion Criteria:\n\nPart I, II and III:\n\n* Has a history of stroke, chronic seizures or major neurological disease;\n* Has a history of cancer;\n* Is a nursing mother;\n\nPart III only:\n\n* Has nonplaque forms of psoriasis;\n* Has current drug-induced psoriasis;\n* Has received phototherapy, systemic medications/treatments, or used topical medication that could affect psoriasis;\n* Has used any systemic immunosuppressants or biologics within the past 4 weeks.'}, 'identificationModule': {'nctId': 'NCT01140061', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A 3-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of MK-0873 Following Cumulative Patch and Repeated Max Area Applications in Healthy Subjects and Psoriasis Patients', 'orgStudyIdInfo': {'id': '0873-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A - MK-0873 5.1 mg', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patch), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg of MK- 0873) once daily for 21 days.', 'interventionNames': ['Drug: MK-0873 Patch', 'Drug: Placebo Patch', 'Drug: Plain patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel A - Placebo', 'description': 'In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days.', 'interventionNames': ['Drug: Placebo Patch', 'Drug: Plain patch']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B - MK-0873 25 mg', 'description': 'In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK- 0873) twice daily for 10 days.', 'interventionNames': ['Drug: MK-0873 Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel B - Placebo', 'description': 'In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.', 'interventionNames': ['Drug: Placebo Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C - MK-0873 100 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.', 'interventionNames': ['Drug: MK-0873 Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel C - Placebo', 'description': 'In Part II, healthy participants received skin application of placebo cream once daily for 10 days.', 'interventionNames': ['Drug: Placebo Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Panel D - MK-0873 200 mg', 'description': 'In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.', 'interventionNames': ['Drug: MK-0873 Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel D - Placebo', 'description': 'In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.', 'interventionNames': ['Drug: Placebo Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Panel E and Extension - MK-0873 200 mg', 'description': 'In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.', 'interventionNames': ['Drug: MK-0873 Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel E and Extension - Placebo', 'description': 'In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.', 'interventionNames': ['Drug: Placebo Cream']}], 'interventions': [{'name': 'MK-0873 Patch', 'type': 'DRUG', 'description': 'MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873', 'armGroupLabels': ['Panel A - MK-0873 5.1 mg']}, {'name': 'MK-0873 Cream', 'type': 'DRUG', 'description': 'MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873', 'armGroupLabels': ['Panel B - MK-0873 25 mg', 'Panel C - MK-0873 100 mg', 'Panel D - MK-0873 200 mg', 'Panel E and Extension - MK-0873 200 mg']}, {'name': 'Placebo Patch', 'type': 'DRUG', 'description': 'Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches', 'armGroupLabels': ['Panel A - MK-0873 5.1 mg', 'Panel A - Placebo']}, {'name': 'Placebo Cream', 'type': 'DRUG', 'description': 'Placebo cream matching MK-0873 0.05%, 0.5%, or 2%', 'armGroupLabels': ['Panel B - Placebo', 'Panel C - Placebo', 'Panel D - Placebo', 'Panel E and Extension - Placebo']}, {'name': 'Plain patch', 'type': 'DRUG', 'description': 'Plain patch containing no MK-0873 or placebo', 'armGroupLabels': ['Panel A - MK-0873 5.1 mg', 'Panel A - Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}