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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Clostridium Difficile Associated Diarrhea (CDAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

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

Interventions

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Surotomycin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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CB-183,315

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes