Rosuvastatin Interethnic PK Study



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:4/2/2016
Start Date:February 2015
Contact:Hsin-Fang Wu, PhD candidate
Email:hf.wu@ucsf.edu
Phone:+14154765890

Use our guide to learn which trials are right for you!

Rosuvastatin Pharmacokinetic (PK) Study in Caucasian and Asian Morbid Obese Patients

Statins are the first-line and most commonly prescribed drugs for the prevention of
cardiovascular diseases and stroke in the world. Our preliminary studies suggest that
Caucasians might have a higher risk of developing potentially life-threatening drug-drug
interactions than Asians when taking statins. Drug-drug interactions occur in the body when
two or more drugs interact in a way that alters their effectiveness and/or toxicity. These
interactions are becoming an increasingly severe problem with statin usage since patients at
higher risk for cardiovascular diseases also take statins combined with many other drugs,
such as antihypertensive and diabetic drugs. Our study is aimed at understanding the
molecular factors and providing a sound basis for the interethnic dosage and response
differences for statins.

Drug-transporting proteins in intestine and liver tissues are responsible for taking up
statins into the blood. It is hypothesized that there are interethnic function differences
of these proteins and that they account for differences in statin blood levels between
Caucasians and Asians and the frequency and/or severity of their respective drug-drug
interactions. A clinical study will be conducted with Caucasian and Asian subjects
undergoing gastric bypass surgery so excess intestine and liver tissue can be acquired as
part of the standard procedure. Protein levels will be quantified in the tissues and
correlate them with different statin blood levels.


Inclusion Criteria:

- Subjects that are scheduled for bariatric surgery.

- Subjects that are able and willing to donate surplus intestinal tissue.

- Subjects with solute carrier organic anion transporter *1 (SLCO1B1) and breast cancer
resistant protein (BCRP) 421CC genotypes.

- White/Caucasian/European and Asian/East Asian heritage individuals, male or female,
18 years of age or older.

- BMI between 30-55 kg/m2

- Be able to read, speak, and understand English(UCSF) and Chinese(Taiwan).

- Subjects capable of providing informed consent and completing the requirements of the
study.

Exclusion Criteria:

- Subjects with active liver and kidney problems, severe cardiovascular diseases, type
I diabetes, advanced pulmonary disease, and cancers.

- Subjects on chronic prescription or over the counter medication that have previously
been reported to exhibit drug-drug interactions with rosuvastatin and cannot be
stopped two weeks prior to and during the study, including gemfibrozil, cyclosporine,
atazanavir, lopinavir and ritonavir.

- Subjects incapable of multiple blood draws (HCT < 30mg/dL).

- Subjects with a history of rhabdomyolysis.

- Subjects with a history of drug-related myalgias.

- Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias.

- Subjects with a history of GI bleed or peptic ulcer disease.

- Subjects with a recent history of trauma.

- Subjects who smoke tobacco or have ongoing alcohol or illegal drug use.

- Subjects who are pregnant, lactating, or trying to conceive during the study period.

- Subjects allergic to rosuvastatin or any known component of the medications.
We found this trial at
1
site
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials