A Phase 1 interventional study of Apixaban alone and Cyclosporine in Venous Thromboembolism, Pharmacokinetics and Healthy, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-11.
Sponsored by Thomas Jefferson University · Phase 1, Interventional, and Basic science
This study aims to evaluate the pharmacokinetics (PK) of apixaban when co-administered with cyclosporine and tacrolimus in healthy volunteers. The study participants will receive apixaban alone, cyclosporine followed by apixaban and tacrolimus followed by apixaban.
Life- and graft-threatening complications in solid organ transplant patients have been greatly reduced due to the potent immunosuppressive agents like calcineurin inhibitors (CNI) that include cyclosporine and tacrolimus. Venous thromboembolism (clots in legs or lungs) in transplant recipients is often difficult to manage due to polypharmacy and potential for drug interactions. More than 90% of renal transplant (RT) recipients are maintained on a CNI-based immunosuppressive regimen. Cyclosporine is an inhibitor of many metabolic pathways including cytochrome P450 (CYP) 3A4, permeability glycoprotein (P-gp) and, breast cancer resistance protein (BCRP). Tacrolimus shares some of the distributive and metabolic pathways of cyclosporine. Apixaban is a combined substrate of CYP3A4, P-gp and, BCRP and thus has the potential for drug interactions with cyclosporine and tacrolimus. Apixaban levels that are too high or too low could be a problem for transplant patients. The purpose of this study is to determine what happens to apixaban blood levels when given in combination with cyclosporine or tacrolimus.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 12 is below the median of 196 across 436 interventional studies indexed under Thromboembolism.
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Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
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Be a female subject, subject
Exclusion Criteria:
Oral apixaban will be administered in healthy volunteers to define baseline apixaban pharmacokinetics
Drug: Apixaban alone
Oral cyclosporine will be administered to steady state in healthy volunteers followed by a single oral dose of apixaban to define apixaban pharmacokinetics in the presence of cyclosporine
Drug: Cyclosporine · Drug: Apixaban
Oral tacrolimus will be administered to steady state in healthy volunteers followed by a single oral dose of apixaban to define apixaban pharmacokinetics in the presence of tacrolimus
Drug: Tacrolimus · Drug: Apixaban
A single dose of 10 mg apixaban administered orally at 0H on Day 1.
Also known as: ELIQUIS
Once daily dose of 100 mg cyclosporine administered orally on Days 1 to 3.
Also known as: NEORAL
Once daily dose of 5 mg tacrolimus administered orally on Days 1 to 3.
Also known as: PROGRAF
A single dose of 10 mg apixaban administered orally on Day 3 immediately following cyclosporine
Also known as: ELIQUIS
A single dose of 10 mg apixaban administered orally on Day 3 immediately following tacrolimus
Also known as: ELIQUIS
Apixaban area under the plasma concentration curve between 0 and 72 hours (AUC(0-72)).
Blood samples for Apixaban pharmacokinetics will be collected prior to apixaban administration at 0H, and then at 1, 2, 3, 4, 6, 12, 24, 48 and, 72 hours in each treatment arm.
Time frame: Days 1-4 (Treatment A), Days 3-6 (Treatment B & C)
Apixaban peak plasma concentration (Cmax)
Blood samples for Apixaban pharmacokinetics will be collected prior to apixaban administration at 0H, and then at 1, 2, 3, 4, 6, 12, 24, 48 and, 72 hours in each treatment arm.
Time frame: Days 1-4 (Treatment A), Days 3-6 (Treatment B & C)
Safety and tolerability of apixaban when co-administered with cyclosporine assessed by capturing adverse events and laboratory safety tests
Safety and tolerability of apixaban when co-administered with cyclosporine based on adverse events reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests
Time frame: Day 1-4 (Treatment A), Day 1-6 (Treatment B & C)
Safety and tolerability of apixaban when co-administered with tacrolimus assessed by capturing adverse events and laboratory safety tests
Safety and tolerability of apixaban when co-administered with tacrolimus based on adverse events reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests
Time frame: Day 1-4 (Treatment A), Day 1-6 (Treatment B & C)
Plan to share: Yes
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Thomas Jefferson University