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

A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Safety and Pharmacokinetic Study of Ascending Doses of CB-183,315 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02835105

Enrollment

Registered

2016-07-15

Start date

2009-01-31

Completion date

2009-03-31

Last updated

2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Associated Diarrhea (CDAD)

Brief 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.

Interventions

DRUGSurotomycin

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Number of participants with an Adverse Event (AE)	Up to Day 9
Number of participants who discontinued study due to an AE	Up to Day 9

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026