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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT00927459
Eligibility Criteria:
Inclusion Criteria:
* Fasting, stable LDL-C ≥ 160 mg/dL
* Fasting, stable triglyceride \< 400 mg/dL
* BMI between 22 and 35 kg/m2, inclusive
* Females must be of non-child bearing potential
* Males of reproductive potential must agree to practice effective contraception throughout the study and for 3 months following infusion
Exclusion Criteria:
* Clinically significant endocrine, hematologic, renal, hepatic, pulmonary, uncontrolled psychiatric, or neurologic disease
* Cancer within 5 years prior to screening
* History of congestive heart failure or chronic heart failure
* Uncontrolled cardiac arrhythmias
* History of coronary heart disease
* Clinically significant abnormal baseline ECG
* History of additional risk factors for torsades de pointes
* Hepatitis B, C, or HIV positive
* Current diagnosis or known history of liver disease
* A marked baseline prolongation of QT/QTc interval
* Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or a creatine phosphokinase (CPK) \>3 x upper limit of normal (ULN) at screening
* Alanine aminotransferase, AST, GGT, or total bilirubin \>2 x ULN at screening
* Serum creatinine \> 1.5 mg/dL
* Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on 2 occasions during screening
* Concomitant use of medications that prolongs the QT/QTc interval
* Treatment with lipid lowering therapy within 30 days prior to screening
* Use of investigational drug within 3 months prior to screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00927459
Study Brief:
Protocol Section:
NCT00927459