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A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)

Primary Purpose

Clostridium Difficile Associated Diarrhea (CDAD)

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Surotomycin
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Associated Diarrhea (CDAD)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease
  • Electrocardiogram (ECG) shows no clinically significant abnormalities
  • Is in good health

Exclusion Criteria:

  • Pregnant or lactating females
  • Has prior exposure to surotomycin
  • 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
  • Participants 18 to 49 years of age that has taken any regular, prescribed, or over-the-counter medication
  • Has any significant concurrent therapies
  • Has a positive drug screen
  • Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen
  • Has donated blood or blood products in the 60 days preceding screening
  • Is an active intravenous drug user or abuses alcohol
  • Has had a malignancy within the last 5 years
  • Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug
  • Has received any antibiotics within 30 days prior to first dose of study drug
  • Has known hypersensitivity to daptomycin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Surotomycin 0.5 g

    Surotomycin 1 g

    Surotomycin 2 g

    Placebo

    Arm Description

    Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

    Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

    Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

    Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

    Outcomes

    Primary Outcome Measures

    Number of participants with an Adverse Event (AE)
    Number of participants who discontinued study treatment due to an AE

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2016
    Last Updated
    July 21, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02835118
    Brief Title
    A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)
    Official Title
    A Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose, Safety and Pharmacokinetic Study of Ascending Doses of Oral CB-183,315 in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clostridium Difficile Associated Diarrhea (CDAD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Surotomycin 0.5 g
    Arm Type
    Experimental
    Arm Description
    Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
    Arm Title
    Surotomycin 1 g
    Arm Type
    Experimental
    Arm Description
    Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
    Arm Title
    Surotomycin 2 g
    Arm Type
    Experimental
    Arm Description
    Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Surotomycin
    Other Intervention Name(s)
    CB-183,315
    Intervention Description
    Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days
    Primary Outcome Measure Information:
    Title
    Number of participants with an Adverse Event (AE)
    Time Frame
    Up to Day 21
    Title
    Number of participants who discontinued study treatment due to an AE
    Time Frame
    Up to Day 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease Electrocardiogram (ECG) shows no clinically significant abnormalities Is in good health Exclusion Criteria: Pregnant or lactating females Has prior exposure to surotomycin 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 Participants 18 to 49 years of age that has taken any regular, prescribed, or over-the-counter medication Has any significant concurrent therapies Has a positive drug screen Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen Has donated blood or blood products in the 60 days preceding screening Is an active intravenous drug user or abuses alcohol Has had a malignancy within the last 5 years Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug Has received any antibiotics within 30 days prior to first dose of study drug Has known hypersensitivity to daptomycin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28347318
    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.
    Results Reference
    derived

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    A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)

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