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:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01062269
Eligibility Criteria:
Inclusion Criteria:
Subjects or generally healthy volunteers are eligible for inclusion if they meet the following inclusion criteria during the Screening Period:
* Men or women 18-70 years of age
* In general good health.
* Subjects are capable of giving informed consent, or if appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf.
* Subjects are willing and readily able to be contacted for post-study safety phone call assessments one to seven days after the single study visit.
Exclusion Criteria:
* Prior intolerance to bile acid sequestrants
* Women who are either pregnant, or who are not practicing any form of birth control.
* Prior gastrointestinal surgery
* History of ongoing gastrointestinal symptoms (indigestion, constipation, or diarrhea)
* History of bowel obstruction, malabsorption, or irritable bowel syndrome
* History of esophageal disease
* Current or past history of gall bladder disease
* Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to visit 1.
* Diagnosis of diabetes mellitus
* Known history of triglyceride levels \> 300 mg/dl.
* History of alcohol or drug abuse within 1 year of study entry
* Alcohol intake that exceeds more than 2 units of alcohol drinks per day
* Blood donation within 8 weeks of the study or anticipation of blood donation during the study.
* Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within 30 of visit 1).
* Any other situation in which the Investigator makes the judgment that participation in the study would not be in the best interest of the study participant, or in the best interest of providing reliable study data.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01062269
Study Brief:
Protocol Section:
NCT01062269