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Rosuvastatin Interethnic PK Study (RST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215174
Recruitment Status : Terminated (IRB approval expired)
First Posted : August 13, 2014
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
E-DA Hospital
Information provided by (Responsible Party):
University of California, San Francisco

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 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.


Condition or disease Intervention/treatment Phase
Statin Pharmacokinetics Pre and Post Gastric Bypass Surgery Drug: Rosuvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Rosuvastatin Pharmacokinetic (PK) Study in Caucasian and Asian Morbid Obese Patients
Study Start Date : February 2015
Actual Primary Completion Date : December 6, 2018
Actual Study Completion Date : December 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Asians
Drug: Rosuvastatin Rosuvastatin 20mg po x1 Other Name: Crestor
Drug: Rosuvastatin
Rosuvastatin 20mg po x1
Other Name: Crestor

Experimental: Caucasians
Drug: Rosuvastatin Rosuvastatin 20mg po x1 Other Name: Crestor
Drug: Rosuvastatin
Rosuvastatin 20mg po x1
Other Name: Crestor




Primary Outcome Measures :
  1. Area-under-the-concentration curve (AUC) of rosuvastatin [ Time Frame: 0,1,2,3,4,5,6,8,12,24,36,48 hr post dosing ]

Secondary Outcome Measures :
  1. Change in oral clearance of rosuvastatin [ Time Frame: Pre-surgery period: 48 hr after dosing; post-surgery period: 48 hr after dosing. Two periods separated by at least two months. ]
    Changes in oral clearance of rosuvastatin within gastric bypass surgery will be analyzed using the ratio of areas under the systemic concentration curves (AUCs) from before to after surgery using the bioequivalence criteria of 80-125%. The oral clearance will be calculated based on the plasma data from each of the blood draws after the dosing period is completed (48hr). The pre and post surgery period are separated by at least a 8-week recovery period.

  2. Descriptive comparison of messenger ribonucleic acid (mRNA) and protein expression in the tissues [ Time Frame: Day of the surgery ]
    Tissue samples will be collected on the day of the surgery.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215174


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Taiwan
E-Da Hospital
Kaohsiung, Taiwan, 82445
Sponsors and Collaborators
University of California, San Francisco
E-DA Hospital
Investigators
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Principal Investigator: Leslie Benet, PhD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02215174    
Other Study ID Numbers: 14-13695.
14-13695 ( Other Identifier: University of California, San Francisco )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by University of California, San Francisco:
Rosuvastatin
PK
Interethnic
Morbid obese
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors