Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 6:52 PM
Study NCT ID:
NCT06814106
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2025-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000728674', 'term': 'MK-0616'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Additional Roles Masked: Sponsor'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 2 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention'}, {'measure': 'Number of Participants Who Discontinue the Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 2 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention'}], 'secondaryOutcomes': [{'measure': 'Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 8 days postdose)', 'description': 'Blood samples will be collected to determine the AUC0-inf of enlicitide chloride'}, {'measure': 'Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 24 hours postdose)', 'description': 'Blood samples will be collected to determine the AUC0-24 of enlicitide chloride'}, {'measure': 'Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 8 days postdose)', 'description': 'Blood samples will be collected to determine the AUC0-last of enlicitide chloride'}, {'measure': 'Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 8 days postdose)', 'description': 'Blood samples will be collected to determine the Cmax of enlicitide chloride'}, {'measure': 'Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 8 days postdose)', 'description': 'Blood samples will be collected to determine the Tmax of enlicitide chloride'}, {'measure': 'Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride', 'timeFrame': '24 hours postdose', 'description': 'Blood samples will be collected to determine the C24 of enlicitide chloride'}, {'measure': 'Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 8 days postdose)', 'description': 'Blood samples will be collected to determine the apparent terminal t1/2 of enlicitide chloride'}, {'measure': 'Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 8 days postdose)', 'description': 'Blood samples will be collected to determine the CL/F of enlicitide chloride'}, {'measure': 'Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 8 days postdose)', 'description': 'Blood samples will be collected to determine the Vz/F of enlicitide chloride'}, {'measure': 'Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Predose and at designated timepoints (up to 8 days postdose)', 'description': 'Blood samples will be collected to determine the percent of reduction of serum LDL-C'}, {'measure': 'Panel C: AUC0-24 of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 24 hours postdose)', 'description': 'Blood samples will be collected to determine the AUC0-24 of enlicitide chloride'}, {'measure': 'Panel C: Cmax of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 14 days postdose)', 'description': 'Blood samples will be collected to determine the Cmax of enlicitide chloride'}, {'measure': 'Panel C: Tmax of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 14 days postdose)', 'description': 'Blood samples will be collected to determine the Tmax of enlicitide chloride'}, {'measure': 'Panel C: C24 of Enlicitide Chloride', 'timeFrame': '24 hours postdose', 'description': 'Blood samples will be collected to determine the C24 of enlicitide chloride'}, {'measure': 'Panel C: Apparent Terminal t1/2 of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 14 days postdose)', 'description': 'Blood samples will be collected to determine the apparent terminal t/2 of enlicitide chloride'}, {'measure': 'Panel C: CL/F of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 14 days postdose)', 'description': 'Blood samples will be collected to determine the CL/F of enlicitide chloride'}, {'measure': 'Panel C: Vz/F of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 14 days postdose)', 'description': 'Blood samples will be collected to determine the Vz/F of enlicitide chloride'}, {'measure': 'Panel C: Accumulation Ratio of Enlicitide Chloride', 'timeFrame': 'Predose and at designated timepoints (up to 14 days postdose)', 'description': 'Blood samples will be collected to determine the accumulation ratio of enlicitide chloride'}, {'measure': 'Panel C: Percent of Reduction of Serum LDL-C', 'timeFrame': 'Predose and at designated timepoints (up to 14 days postdose)', 'description': 'Blood samples will be collected to determine the percent of reduction of serum LDL-C'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria include, but are not limited to:\n\n* Is in good health\n* Has a body mass index ≥19.0 and ≤26.0 kg/m\\^2, inclusive\n\nExclusion Criteria:\n\nExclusion criteria include, but are not limited to:\n\n* Has a history of gastrointestinal disease\n* Has a history of cancer (malignancy)'}, 'identificationModule': {'nctId': 'NCT06814106', 'briefTitle': 'A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0616 in Healthy Chinese Adult Participants.', 'orgStudyIdInfo': {'id': '0616-010'}, 'secondaryIdInfos': [{'id': 'MK-0616-010', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enlicitide Chloride Panel A', 'description': 'Period 1: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast).\n\nPeriod 2: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast) followed by a standard breakfast.', 'interventionNames': ['Drug: Enlicitide Chloride', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Enlicitide Chloride Panel B', 'description': 'Period 1: Participants will receive a single dose of enlicitide chloride dose 2 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast).\n\nPeriod 2: Participants will receive a single dose of enlicitide chloride dose 3 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast).', 'interventionNames': ['Drug: Enlicitide Chloride', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Enlicitide Chloride Panel C', 'description': 'Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast).', 'interventionNames': ['Drug: Enlicitide Chloride', 'Drug: Placebo']}], 'interventions': [{'name': 'Enlicitide Chloride', 'type': 'DRUG', 'otherNames': ['MK-0616'], 'description': 'Oral Capsule', 'armGroupLabels': ['Enlicitide Chloride Panel A', 'Enlicitide Chloride Panel B', 'Enlicitide Chloride Panel C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral capsule matching enlicitide chloride', 'armGroupLabels': ['Enlicitide Chloride Panel A', 'Enlicitide Chloride Panel B', 'Enlicitide Chloride Panel C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharpe & 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'}}}}