A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)
Phase 1
Completed
- Conditions
- Clostridium Difficile Associated Diarrhea (CDAD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT02835105
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surotomycin 0.5 g Surotomycin A single oral dose of 0.5 g surotomycin in hard gelatin capsules Surotomycin 1 g Surotomycin A single oral dose of 1 g surotomycin in hard gelatin capsules Surotomycin 2 g Surotomycin A single oral dose of 2 g surotomycin in hard gelatin capsules Surotomycin 4 g Surotomycin A single oral dose of 4 g surotomycin in hard gelatin capsules Placebo Placebo A single oral dose of placebo for surotomycin in hard gelatin capsules
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method