Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-01-28 @ 4:46 PM
Study NCT ID:
NCT02835118
Status:
COMPLETED
Last Update Posted:
2016-07-22
First Post:
2016-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C574454', 'term': 'CB-183,315'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-07-13', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with an Adverse Event (AE)', 'timeFrame': 'Up to Day 21'}, {'measure': 'Number of participants who discontinued study treatment due to an AE', 'timeFrame': 'Up to Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Clostridium Difficile Associated Diarrhea (CDAD)']}, 'referencesModule': {'references': [{'pmid': '28347318', 'type': 'DERIVED', 'citation': 'Chandorkar G, Zhan Q, Donovan J, Rege S, Patino H. Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers. BMC Pharmacol Toxicol. 2017 Mar 28;18(1):24. doi: 10.1186/s40360-017-0123-z.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and females.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease\n* Electrocardiogram (ECG) shows no clinically significant abnormalities\n* Is in good health\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Has prior exposure to surotomycin\n* Has received an investigational drug or participated in any experimental procedure within1 month prior to study entry and at least 6 half lives from last intake of study drug\n* Participants 18 to 49 years of age that has taken any regular, prescribed, or over-the-counter medication\n* Has any significant concurrent therapies\n* Has a positive drug screen\n* Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen\n* Has donated blood or blood products in the 60 days preceding screening\n* Is an active intravenous drug user or abuses alcohol\n* Has had a malignancy within the last 5 years\n* Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug\n* Has received any antibiotics within 30 days prior to first dose of study drug\n* Has known hypersensitivity to daptomycin'}, 'identificationModule': {'nctId': 'NCT02835118', 'briefTitle': 'A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose, Safety and Pharmacokinetic Study of Ascending Doses of Oral CB-183,315 in Healthy Volunteers', 'orgStudyIdInfo': {'id': '4261-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surotomycin 0.5 g', 'description': 'Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days', 'interventionNames': ['Drug: Surotomycin']}, {'type': 'EXPERIMENTAL', 'label': 'Surotomycin 1 g', 'description': 'Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days', 'interventionNames': ['Drug: Surotomycin']}, {'type': 'EXPERIMENTAL', 'label': 'Surotomycin 2 g', 'description': 'Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days', 'interventionNames': ['Drug: Surotomycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Surotomycin', 'type': 'DRUG', 'otherNames': ['CB-183,315'], 'description': 'Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days', 'armGroupLabels': ['Surotomycin 0.5 g', 'Surotomycin 1 g', 'Surotomycin 2 g']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}