A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Safety and Pharmacokinetic Study of Ascending Doses of CB-183,315 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Surotomycin
- Conditions
- Clostridium Difficile Associated Diarrhea (CDAD)
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 40
- Primary Endpoint
- Number of participants with an Adverse Event (AE)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Surotomycin 0.5 g
A single oral dose of 0.5 g surotomycin in hard gelatin capsules
Intervention: Surotomycin
Surotomycin 1 g
A single oral dose of 1 g surotomycin in hard gelatin capsules
Intervention: Surotomycin
Surotomycin 2 g
A single oral dose of 2 g surotomycin in hard gelatin capsules
Intervention: Surotomycin
Surotomycin 4 g
A single oral dose of 4 g surotomycin in hard gelatin capsules
Intervention: Surotomycin
Placebo
A single oral dose of placebo for surotomycin in hard gelatin capsules
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with an Adverse Event (AE)
Time Frame: Up to Day 9
Number of participants who discontinued study due to an AE
Time Frame: Up to Day 9