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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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

• 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