Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT02835105
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02835105
Study Brief:
Protocol Section:
NCT02835105