Status:
COMPLETED
Drug-Drug Interaction Study With Pravastatin and Cyclosporine
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study will address the following question: Does cyclosporine affect the pharmacokinetics of pravastatin in healthy volunteers? Studies have shown that cyclosporine inhibits the organic anion tran...
Detailed Description
Screening Procedures: Prior to enrollment, subjects will be asked to come to the Clinical and Translational Science (CTSI) Clinical Research Center (CRC) at San Francisco General Hospital (SFGH). The...
Eligibility Criteria
Inclusion
- Carrier of one of the three SLCO1B1 polymorphisms that we are studying (SLCO1B1 521TT, 521TC, 521CC)
- Men or women (women must have negative pregnancy test)
- ages 18 to 45 years
- Caucasian
- Healthy, including no renal or hepatic disease, as determined from plasma creatinine and liver enzyme levels
- No medications currently, except for vitamins and oral contraceptive pills
- Willingness to spend two nights at the San Francisco General Hospital
- Sign informed consent
Exclusion
- Under 18 years old
- Unable to confirm Caucasian ancestry
- Pregnant or lactating women (female subjects will have a urine pregnancy test at the screening visit)
- Prior history of allergic reaction to pravastatin or cyclosporine
- Has a risk of congestive heart failure requiring pharmacologic treatment (medical history)
- Has prior renal or hepatic dysfunction
- Risk of urinary or gastric retention or narrow-angle glaucoma (by medical history examination)
- Impaired renal function (e.g. as suggested by abnormal creatinine clearance, eGFR \< 60 or serum creatinine \> 1.4 mg/dl in females and \> 1.5 mg/dl in males) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction (heart attack), and septicemia, abnormal heart rhythms (tachyarrhythmias; heart beat \> 100 beats per minute)
- Impaired hepatic function (\> 1.5 times the upper limit of normal)
- Evidence of anemia (hemoglobin \<10g)
- Taking medications other than vitamins that could confound study results
- They do not provide informed consent to participate in the study
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01497483
Start Date
December 1 2011
End Date
December 1 2013
Last Update
January 16 2015
Active Locations (1)
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1
San Francisco General Hosptail
San Francisco, California, United States, 94110