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

NCT02835105 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-07-22

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile Associated Diarrhea (CDAD)

Interventions

DRUG

Surotomycin

A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-03-31
Completion
2009-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835105 on ClinicalTrials.gov