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OpenTrials
Completed

NCT Number: NCT02835105

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

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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Key information

Conditions

Clostridium Difficile Associated Diarrhea (CDAD)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surotomycin

Drug

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

Other names: CB-183,315

Placebo

Drug

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

Primary outcomes

  1. Number of participants with an Adverse Event (AE)

    Time frame: Up to Day 9

  2. Number of participants who discontinued study due to an AE

    Time frame: Up to Day 9

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2016
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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