- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02835118
A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)
July 21, 2016 updated by: Merck Sharp & Dohme LLC
A Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose, Safety and Pharmacokinetic Study of Ascending Doses of Oral CB-183,315 in Healthy Volunteers
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surotomycin 0.5 g
Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
|
Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days
Other Names:
|
Experimental: Surotomycin 1 g
Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
|
Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days
Other Names:
|
Experimental: Surotomycin 2 g
Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
|
Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days
Other Names:
|
Placebo Comparator: Placebo
Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days
|
Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with an Adverse Event (AE)
Time Frame: Up to Day 21
|
Up to Day 21
|
Number of participants who discontinued study treatment due to an AE
Time Frame: Up to Day 14
|
Up to Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
July 13, 2016
First Submitted That Met QC Criteria
July 13, 2016
First Posted (Estimate)
July 15, 2016
Study Record Updates
Last Update Posted (Estimate)
July 22, 2016
Last Update Submitted That Met QC Criteria
July 21, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4261-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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