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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Clostridium Difficile Associated Diarrhea (CDAD)

Treatments: Drug: Placebo; Drug: Surotomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02835105

4261-008

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups, including a placebo group

Surotomycin 0.5 g

Experimental group

Description:

A single oral dose of 0.5 g surotomycin in hard gelatin capsules

Treatment:

Drug: Surotomycin

Surotomycin 1 g

Experimental group

Description:

A single oral dose of 1 g surotomycin in hard gelatin capsules

Treatment:

Drug: Surotomycin

Surotomycin 2 g

Experimental group

Description:

A single oral dose of 2 g surotomycin in hard gelatin capsules

Treatment:

Drug: Surotomycin

Surotomycin 4 g

Experimental group

Description:

A single oral dose of 4 g surotomycin in hard gelatin capsules

Treatment:

Drug: Surotomycin

Placebo

Placebo Comparator group

Description:

A single oral dose of placebo for surotomycin in hard gelatin capsules

Treatment:

Drug: Placebo