Status:
TERMINATED
Rosuvastatin Interethnic PK Study
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
E-DA Hospital
Conditions:
Statin Pharmacokinetics Pre and Post Gastric Bypass Surgery
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02215174
Start Date
February 1 2015
End Date
December 6 2018
Last Update
January 18 2020
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
E-Da Hospital
Kaohsiung City, Taiwan, 82445