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

Clostridium Difficile Associated Diarrhea (CDAD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835118
• Other study ID #: 4261-009
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2016
• Last updated: July 21, 2016
• Start date: July 2009
• Est. completion date: October 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 oral doses of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and females.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2009
• Est. primary completion date: October 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

• 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

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

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 21	Yes
Primary	Number of participants who discontinued study treatment due to an AE		Up to Day 14	Yes