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

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

NCT02835118

4261-009

Details and patient eligibility

About

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.

Enrollment: 30 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

Surotomycin 0.5 g

Experimental group

Description:

Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

Treatment:

Drug: Surotomycin

Surotomycin 1 g

Experimental group

Description:

Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

Treatment:

Drug: Surotomycin

Surotomycin 2 g

Experimental group

Description:

Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

Treatment:

Drug: Surotomycin

Placebo

Placebo Comparator group

Description:

Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

Treatment:

Drug: Placebo