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Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus

NCT03083782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-10-11

No results posted yet for this study

Summary

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.

Conditions

  • Venous Thromboembolism
  • Pharmacokinetics
  • Healthy

Interventions

DRUG

Apixaban alone

A single dose of 10 mg apixaban administered orally at 0H on Day 1.

DRUG

Cyclosporine

Once daily dose of 100 mg cyclosporine administered orally on Days 1 to 3.

DRUG

Tacrolimus

Once daily dose of 5 mg tacrolimus administered orally on Days 1 to 3.

DRUG

Apixaban

A single dose of 10 mg apixaban administered orally on Day 3 immediately following cyclosporine

DRUG

Apixaban

A single dose of 10 mg apixaban administered orally on Day 3 immediately following tacrolimus

Sponsors & Collaborators

Principal Investigators

  • Walter K Kraft, M.D. · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2017-06-05
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083782 on ClinicalTrials.gov