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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02835118 -
A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)
|
Phase 1 |