This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Purpose: The purpose of this multicenter research study is to learn about how Legalon , silymarin, is distributed throughout the body, the effect of food on the absorption of silymarin, and the safety of different silymarin doses in patients with varying severity of liver disease. We are also trying to identify ifpatients have genetic differences in the way they eliminate silymarin from the body.Participants: Subjects with chronic hepatitis C virus (HCV) who have failed to respond to previous interferon-based therapies, and subjects with non-alcoholic fatty liver disease (NAFLD) will be enrolled in this study.Procedures (methods): Seven dose groups with 8 subjects per group for a total of fifty-six (56) subjects with non-cirrhotic liver disease will be enrolled at four sites. The pharmacokinetics for each population will be evaluated after single and multiple doses of silymarin. Since this is a dose escalation study, the pharmacokinetic analysis will take place before entering into the next level of dosing. HCV-positive subjects will be studied at 140, 280 (2 study groups), 560 and 700 mg dose levels (Groups 1, 2, 3, 5, 7). Subjects with NAFLD will be evaluated at 280 and 560 mg dose levels (Groups 4, 6).

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000046-48
Application #
7716889
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2008-04-02
Project End
2008-05-31
Budget Start
2008-04-02
Budget End
2008-05-31
Support Year
48
Fiscal Year
2008
Total Cost
$20,125
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Venuto, Charles S; Lim, Jihoon; Messing, Susan et al. (2018) Inflammation investigated as a source of pharmacokinetic variability of atazanavir in AIDS Clinical Trials Group protocol A5224s. Antivir Ther 23:345-351
Malinen, Melina M; Kauttonen, Antti; Beaudoin, James J et al. (2018) Novel In Vitro Method Reveals Drugs that Inhibit Solute Transporter Alpha/Beta (OST?/?). Mol Pharm :
Li, Binglan; Verma, Shefali S; Veturi, Yogasudha C et al. (2018) Evaluation of PrediXcan for prioritizing GWAS associations and predicting gene expression. Pac Symp Biocomput 23:448-459
Hanly, John G; Li, Qiuju; Su, Li et al. (2018) Cerebrovascular Events in Systemic Lupus Erythematosus: Results From an International Inception Cohort Study. Arthritis Care Res (Hoboken) 70:1478-1487
Barber, Megan R W; Hanly, John G; Su, Li et al. (2018) Economic Evaluation of Lupus Nephritis in the Systemic Lupus International Collaborating Clinics Inception Cohort Using a Multistate Model Approach. Arthritis Care Res (Hoboken) 70:1294-1302
Rini, Christine; Vu, Maihan B; Lerner, Hannah et al. (2018) A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain. Palliat Support Care 16:155-169
Little, Jayne; Parker, Ben; Lunt, Mark et al. (2018) Glucocorticoid use and factors associated with variability in this use in the Systemic Lupus International Collaborating Clinics Inception Cohort. Rheumatology (Oxford) 57:677-687
Abdullah, Lubna H; Coakley, Raymond; Webster, Megan J et al. (2018) Mucin Production and Hydration Responses to Mucopurulent Materials in Normal versus Cystic Fibrosis Airway Epithelia. Am J Respir Crit Care Med 197:481-491
Martin, Maureen P; Naranbhai, Vivek; Shea, Patrick R et al. (2018) Killer cell immunoglobulin-like receptor 3DL1 variation modifies HLA-B*57 protection against HIV-1. J Clin Invest 128:1903-1912
Haas, David W; Bradford, Yuki; Verma, Anurag et al. (2018) Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events. Pharmacogenet Genomics 28:179-187

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