A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)

Study Overview
=================
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.

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

Conditions
-----------------
Clostridium Difficile Associated Diarrhea (CDAD)

Intervention / Treatment
-----------------
* Drug: Surotomycin
* Drug: Placebo


Participation Criteria
=================
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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>A single oral dose of 0.5 g surotomycin in hard gelatin capsules | Drug: Surotomycin<br>* A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules<br>* Other names: CB-183,315;|
| Experimental: Surotomycin 1 g<br>A single oral dose of 1 g surotomycin in hard gelatin capsules | Drug: Surotomycin<br>* A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules<br>* Other names: CB-183,315;|
| Experimental: Surotomycin 2 g<br>A single oral dose of 2 g surotomycin in hard gelatin capsules | Drug: Surotomycin<br>* A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules<br>* Other names: CB-183,315;|
| Experimental: Surotomycin 4 g<br>A single oral dose of 4 g surotomycin in hard gelatin capsules | Drug: Surotomycin<br>* A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules<br>* Other names: CB-183,315;|
| Placebo Comparator: Placebo<br>A single oral dose of placebo for surotomycin in hard gelatin capsules | Drug: Placebo<br>* A single oral dose of placebo for surotomycin in hard gelatin capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an Adverse Event (AE) |  | Up to Day 9 | 
| Number of participants who discontinued study due to an AE |  | Up to Day 9 |