A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)

Phase 1

Completed

• Conditions: Clostridium Difficile Associated Diarrhea (CDAD)
• Interventions: Drug: Placebo; Drug: Surotomycin

• Registration Number: NCT02835118
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and females.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-15
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease
• Electrocardiogram (ECG) shows no clinically significant abnormalities
• Is in good health

Exclusion Criteria

• Pregnant or lactating females
• Has prior exposure to surotomycin
• 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 that has 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 donated blood or blood products 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 known hypersensitivity to daptomycin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
Surotomycin 0.5 g	Surotomycin	Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
Surotomycin 1 g	Surotomycin	Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
Surotomycin 2 g	Surotomycin	Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

Primary Outcome Measures

Name	Time	Method
Number of participants with an Adverse Event (AE)	Up to Day 21
Number of participants who discontinued study treatment due to an AE	Up to Day 14