Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT06567002
Status:
TERMINATED
Last Update Posted:
2024-12-04
First Post:
2024-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MK-6552 and the Effect of Food in Healthy Participants (MK-6552-006)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Business Reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-6552 in a Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-6552.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 in a Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the AUC0-inf of MK-6552.'}, {'measure': 'Maximum Concentration (Cmax) of MK-6552 in a Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the Cmax of MK-6552.'}, {'measure': 'Concentration at 8 hours (C8h) of MK-6552 in a Fasted State', 'timeFrame': '8 hours postdose', 'description': 'Blood samples will be collected to determine the C8h of MK-6552.'}, {'measure': 'Concentration at 16 hours (C16h) of MK-6552 in a Fasted State', 'timeFrame': '16 hours postdose', 'description': 'Blood samples will be collected to determine the C16h of MK-6552.'}, {'measure': 'Time to maximum concentration (Tmax) of MK-6552 in a Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the Tmax of MK-6552.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-6552 in a Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the t1/2 of MK-6552.'}], 'secondaryOutcomes': [{'measure': 'AUC0-last of MK-6552 in a Fed or Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-6552.'}, {'measure': 'AUC0-inf of MK-6552 in a Fed or Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the AUC0-inf of MK-6552.'}, {'measure': 'Cmax of MK-6552 in a Fed or Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the Cmax of MK-6552.'}, {'measure': 'C8h of MK-6552 in a Fed or Fasted State', 'timeFrame': '8 hours postdose', 'description': 'Blood samples will be collected to determine the C8h of MK-6552.'}, {'measure': 'C16h of MK-6552 in a Fed or Fasted State', 'timeFrame': '16 hours postdose', 'description': 'Blood samples will be collected to determine the C16h of MK-6552.'}, {'measure': 'Tmax of MK-6552 in a Fed or Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the Tmax of MK-6552.'}, {'measure': 't1/2 of MK-6552 in a Fed or Fasted State', 'timeFrame': 'Predose and at designated timepoints approximately up to 3 days postdose', 'description': 'Blood samples will be collected to determine the t1/2 of MK-6552.'}, {'measure': 'Number of participants with one or more adverse events (AE)', 'timeFrame': 'Up to approximately day 35', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who experience an AE will be reported.'}, {'measure': 'Number of participants discontinuing from study therapy due to AE', 'timeFrame': 'Up to approximately day 35', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to learn what happens to levels of MK-6552 in the blood when MK-6552 is given in different forms to healthy adult participants under fasted and fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The main inclusion criteria include but are not limited to the following:\n\n* Be in good health\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* History of cancer (malignancy)\n* Has received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention'}, 'identificationModule': {'nctId': 'NCT06567002', 'briefTitle': 'A Study of MK-6552 and the Effect of Food in Healthy Participants (MK-6552-006)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Evaluate the Pharmacokinetics of Single Dose Formulations of MK-6552 and the Effect of Food in Healthy Study Participants', 'orgStudyIdInfo': {'id': '6552-006'}, 'secondaryIdInfos': [{'id': 'MK-6552-006', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1: (Treatment A) → (Treatment B) → (Treatment C) → (Treatment B) → (Treatment C)', 'description': 'Period 1: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive Treatment C single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.', 'interventionNames': ['Drug: MK-6552']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2: (Treatment B) → (Treatment C) → (Treatment A) → (Treatment B) → (Treatment C)', 'description': 'Period 1: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.', 'interventionNames': ['Drug: MK-6552']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3: (Treatment C) → (Treatment A) → (Treatment B) → (Treatment B) → (Treatment C)', 'description': 'Period 1: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.', 'interventionNames': ['Drug: MK-6552']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4: (Treatment A) → (Treatment C) → (Treatment B) → (Treatment C) → (Treatment B)', 'description': 'Period 1: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.', 'interventionNames': ['Drug: MK-6552']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5: (Treatment B) → (Treatment A) → (Treatment C) → (Treatment C) → (Treatment B)', 'description': 'Period 1: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.', 'interventionNames': ['Drug: MK-6552']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6: (Treatment C) → (Treatment B) → (Treatment A) → (Treatment C) → (Treatment B)', 'description': 'Period 1: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.', 'interventionNames': ['Drug: MK-6552']}], 'interventions': [{'name': 'MK-6552', 'type': 'DRUG', 'description': 'Oral Administration', 'armGroupLabels': ['Sequence 1: (Treatment A) → (Treatment B) → (Treatment C) → (Treatment B) → (Treatment C)', 'Sequence 2: (Treatment B) → (Treatment C) → (Treatment A) → (Treatment B) → (Treatment C)', 'Sequence 3: (Treatment C) → (Treatment A) → (Treatment B) → (Treatment B) → (Treatment C)', 'Sequence 4: (Treatment A) → (Treatment C) → (Treatment B) → (Treatment C) → (Treatment B)', 'Sequence 5: (Treatment B) → (Treatment A) → (Treatment C) → (Treatment C) → (Treatment B)', 'Sequence 6: (Treatment C) → (Treatment B) → (Treatment A) → (Treatment C) → (Treatment B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'QPS-MRA, LLC-Early Phase ( Site 0001)', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}], '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'}}}}