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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT00630734
Eligibility Criteria:
Inclusion Criteria:
* Healthy, HIV-negative volunteers
Exclusion Criteria:
* Currently active or chronic cardiovascular, hepatic, renal, pancreatic, gastrointestinal, neurologic, hematologic, psychiatric, metabolic, respiratory, inflammatory, or infectious disease
* Chronic pancreatitis
* History of rhabdomyolysis
* History of statin-associated myopathy
* Active malignancy
* History of significant skin disease, food allergy, drug allergy, dermatitis, eczema, psoriasis
* Pregnancy/breastfeeding
* HIV positive and/or AIDS
* serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range \[ULN\]);
* hemoglobin grade 1 or greater (≤ 10.9 g/dL);
* platelet count grade 1 or greater (≤ 124.999 x 109/L);
* absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L);
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN);
* total bilirubin grade 1 or greater (≥ 1.1 x ULN)
* serum lipase grade 1 or greater (≥ 1.1 x ULN)
* serum amylase grade 1 or greater (≥ 1.1 x ULN)
* any other laboratory abnormality of grade 2 or above
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00630734
Study Brief:
Protocol Section:
NCT00630734