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

Phase 1

Completed

• Conditions: Clostridium Difficile Associated Diarrhea (CDAD)
• Interventions: Drug: Surotomycin; Drug: Placebo

• Registration Number: NCT02835105
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-15
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surotomycin 0.5 g	Surotomycin	A single oral dose of 0.5 g surotomycin in hard gelatin capsules
Surotomycin 1 g	Surotomycin	A single oral dose of 1 g surotomycin in hard gelatin capsules
Surotomycin 2 g	Surotomycin	A single oral dose of 2 g surotomycin in hard gelatin capsules
Surotomycin 4 g	Surotomycin	A single oral dose of 4 g surotomycin in hard gelatin capsules
Placebo	Placebo	A single oral dose of placebo for surotomycin in hard gelatin capsules

Primary Outcome Measures

Name	Time	Method
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