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

NCT02835118 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

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 oral doses of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and females.

Conditions

  • Clostridium Difficile Associated Diarrhea (CDAD)

Interventions

DRUG

Surotomycin

Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days

DRUG

Placebo

Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days

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
2009-07-31
Primary Completion
2009-10-31
Completion
2009-10-31

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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 NCT02835118 on ClinicalTrials.gov