NCT02835118

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Clostridium Difficile Associated Diarrhea (CDAD)

Interventions

Type	Name	Description
DRUG	Surotomycin	Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days
DRUG	Placebo	Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2016-07-15
• Last updated: 2016-07-22