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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose, Safety and Pharmacokinetic Study of Ascending Doses of Oral CB-183,315 in Healthy Volunteers

Conditions
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Clostridium Difficile Associated Diarrhea (CDAD)

Intervention / Treatment
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* Drug: Surotomycin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surotomycin 0.5 g<br>Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days | Drug: Surotomycin<br>* Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days<br>* Other names: CB-183,315;|
| Experimental: Surotomycin 1 g<br>Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days | Drug: Surotomycin<br>* Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days<br>* Other names: CB-183,315;|
| Experimental: Surotomycin 2 g<br>Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days | Drug: Surotomycin<br>* Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days<br>* Other names: CB-183,315;|
| Placebo Comparator: Placebo<br>Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days | Drug: Placebo<br>* Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an Adverse Event (AE) |  | Up to Day 21 | 
| Number of participants who discontinued study treatment due to an AE |  | Up to Day 14 |