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

Clostridium Difficile Associated Diarrhea (CDAD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835105
• Other study ID #: 4261-008
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2016
• Last updated: July 21, 2016
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: July 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile Associated Diarrhea (CDAD)
• Diarrhea

Intervention

Drug:
• Surotomycin
A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules
• Placebo
A single oral dose of placebo for surotomycin in hard gelatin capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with an Adverse Event (AE)		Up to Day 9	Yes
Primary	Number of participants who discontinued study due to an AE		Up to Day 9	Yes