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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT01487460
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female subjects age 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
* OR untreated dyslipidemic patients.
* Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.
* Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Exclusion Criteria:
* Use of other investigational drugs at the time of enrollment.
* Active treatment for type 1 diabetes or type 2 diabetes mellitus.
* A past medical history of ECG abnormalities, documented cardiac arrhythmias or cardiovascular diseases.
* History of malignancy of any organ system, treated or untreated, within the past 5 years.
* Pregnant or nursing (lactating) women.
* Smokers.
* Use of any prescription drugs, herbal supplements and/or over-the-counter (OTC) medication, dietary supplements.
* History of drug or alcohol abuse within the 12 months prior to dosing.
* Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01487460
Study Brief:
Protocol Section:
NCT01487460