Back to resultsA Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)
Primary Purpose
Clostridium Difficile Associated Diarrhea (CDAD)
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Surotomycin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Difficile Associated Diarrhea (CDAD)
Eligibility Criteria
Inclusion Criteria:
- Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease or gastroesophageal reflux disease documented on endoscopy
- Electrocardiogram (ECG) shows no clinically significant abnormalities
- Is able to swallow capsules
- is in good health
Exclusion Criteria:
- Pregnant or lactating females
- Has had Clostridium (C.) difficile disease within 1 year prior to entry into the study
- 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 had 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 given more than 450 mL of blood (one unit) 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 been hospitalized within the past 30 days prior to Study Day 1
- Has known hypersensitivity to daptomycin
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Surotomycin 0.5 g
Surotomycin 1 g
Surotomycin 2 g
Surotomycin 4 g
Placebo
Arm Description
A single oral dose of 0.5 g surotomycin in hard gelatin capsules
A single oral dose of 1 g surotomycin in hard gelatin capsules
A single oral dose of 2 g surotomycin in hard gelatin capsules
A single oral dose of 4 g surotomycin in hard gelatin capsules
A single oral dose of placebo for surotomycin in hard gelatin capsules
Outcomes
Primary Outcome Measures
Number of participants with an Adverse Event (AE)
Number of participants who discontinued study due to an AE
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02835105
Brief Title
A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)
Official Title
A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Safety and Pharmacokinetic Study of Ascending Doses of CB-183,315 in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 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 a single oral dose of surotomycin (CB-183,315) at ascending dose levels when given to 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
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surotomycin 0.5 g
Arm Type
Experimental
Arm Description
A single oral dose of 0.5 g surotomycin in hard gelatin capsules
Arm Title
Surotomycin 1 g
Arm Type
Experimental
Arm Description
A single oral dose of 1 g surotomycin in hard gelatin capsules
Arm Title
Surotomycin 2 g
Arm Type
Experimental
Arm Description
A single oral dose of 2 g surotomycin in hard gelatin capsules
Arm Title
Surotomycin 4 g
Arm Type
Experimental
Arm Description
A single oral dose of 4 g surotomycin in hard gelatin capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A single oral dose of placebo for surotomycin in hard gelatin capsules
Intervention Type
Drug
Intervention Name(s)
Surotomycin
Other Intervention Name(s)
CB-183,315
Intervention Description
A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single oral dose of placebo for surotomycin in hard gelatin capsules
Primary Outcome Measure Information:
Title
Number of participants with an Adverse Event (AE)
Time Frame
Up to Day 9
Title
Number of participants who discontinued study due to an AE
Time Frame
Up to Day 9
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 or gastroesophageal reflux disease documented on endoscopy
Electrocardiogram (ECG) shows no clinically significant abnormalities
Is able to swallow capsules
is in good health
Exclusion Criteria:
Pregnant or lactating females
Has had Clostridium (C.) difficile disease within 1 year prior to entry into the study
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 had 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 given more than 450 mL of blood (one unit) 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 been hospitalized within the past 30 days prior to Study Day 1
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 Single Doses of Surotomycin in Healthy Participants (MK-4261-008)
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