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

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

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Associated Diarrhea (CDAD)
• Intervention / Treatment: Drug: Surotomycin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surotomycin 0.5 g; A single oral dose of 0.5 g surotomycin in hard gelatin capsules	Drug: Surotomycin; A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules; Other Names: CB-183,315
Experimental: Surotomycin 1 g; A single oral dose of 1 g surotomycin in hard gelatin capsules	Drug: Surotomycin; A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules; Other Names: CB-183,315
Experimental: Surotomycin 2 g; A single oral dose of 2 g surotomycin in hard gelatin capsules	Drug: Surotomycin; A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules; Other Names: CB-183,315
Experimental: Surotomycin 4 g; A single oral dose of 4 g surotomycin in hard gelatin capsules	Drug: Surotomycin; A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules; Other Names: CB-183,315
Placebo Comparator: Placebo; A single oral dose of placebo for surotomycin in hard gelatin capsules	Drug: Placebo; A single oral dose of placebo for surotomycin in hard gelatin capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Estimate): July 22, 2016
• Last Update Submitted That Met QC Criteria: July 21, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: 4261-008