Status:
COMPLETED
Drug-Drug Interaction Between Rifampin and Fluvastatin
Lead Sponsor:
University of California, San Francisco
Conditions:
Drug-drug Interaction
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The effect of organic anion transporting polypeptide 1B1 (OATP1B1) transporter inhibition at clinical doses of fluvastatin, a biopharmaceutics drug disposition classification system (BDDCS) class 1 dr...
Detailed Description
The effect of rifampin on the pharmacokinetics of fluvastatin will be studied in healthy volunteers in a two arms, two-period, randomized, unblinded, crossover clinical trial. In the first arm, subjec...
Eligibility Criteria
Inclusion
- Healthy male or female, ages 18-65 years old, with no current medical conditions or active diagnoses as determined by the study doctor based on history, physical exam, and laboratory evaluations.
- Subjects who take no other medications two weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications, dietary supplements, or drugs of abuse.
- Subjects able to maintain adequate birth control during the study independent of hormonal contraceptives (including hormonal intrauterine devices (IUDs)). Adequate methods of contraception include use of condoms and copper IUDs.
- Subjects able to abstain from grapefruit, grapefruit juice, oranges, orange juice, caffeinated beverages and/or alcoholic beverages from 7am the day before the study to completion of that study day.
- Participants determined to have normal liver and kidney function as measured at baseline ( alanine aminotransferase (ALT): ≤ 2x upper level of normal (ULN), aspartate aminotransferase (AST): ≤ 2x ULN, serum creatinine (SCr): ≤ 1.5x ULN, T. Bili: 0.1-1.2mg/dL, Albumin: 3.4 - 4.7 mg/dL).
- BMI between 18.0 - 30 kg/m2 o Subjects capable of fasting from food and beverages at least 8 hours prior to medication dosing.
- Be able to read, speak, and understand English.
- Subjects capable of providing informed consent and completing the requirements of the study.
Exclusion
- Subjects with active medical problems
- Subjects on chronic prescription or over the counter (OTC) medication that cannot be stopped 2 weeks prior to and during the study.
- 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 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 fluvastatin or rifampin or any known component of the medications
- Anyone who in the opinion of the study investigators is unable to do the study
Key Trial Info
Start Date :
April 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04029584
Start Date
April 25 2019
End Date
April 25 2020
Last Update
September 8 2021
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143